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DXN

System, Measurement, Blood-Pressure, Non-Invasive

产品代码
DXN
器械名称
System, Measurement, Blood-Pressure, Non-Invasive
管理类别
第 2 类（Class II）
21 CFR 条款
21 CFR 870.1130
FDA 专业组
Cardiovascular
上市路径
需提交 510(k) 上市前通告
标记
可走第三方审查
该代码近三年的 510(k)
1222 件

该代码近三年的 510(k)（85 件）

数据窗口为最近三年。最新一件：2026-08-26。

510(k) 号批准日期申请人器械名称
K2613942026-08-26JOYTECH Healthcare Co., Ltd.Arm-type Fully Automatic Digital Blood Pressure Moni 摘要
K2610612026-08-13Wellvii, Inc.BP Go (BPP-855) 摘要
K2534252026-08-13Joytech Healthcare Co. , Ltd.Arm-type Fully Automatic Digital Blood Pressure Moni 摘要
K2611362026-07-23Guangzhou Daxin Health Technology Co.,Blood Pressure Monitor (M501,M501A,M502,M502A,M502C, 摘要
K2610822026-07-23Microlife CorporationMicrolife Wrist Blood Pressure Monitor , (Model BPHJ 摘要
K2531262026-06-18Shenzhen Ziqing Medical Equipment Co.,Wrist Blood Pressure Monitor (XW-05) 摘要
K2606932026-06-1680 Beats Medical GmbHVicorderCS (VCS-SYS-1100) 摘要
K2530592026-06-15Tournicare Pty, Ltd.Tournicare ARMA Automatic Blood Pressure Monitor (AR 摘要
K2531242026-06-03Shenzhen Ziqing Medical Equipment Co.,Upper arm electronic blood pressure monitor (XB-01) 摘要
K2535702026-05-20Shenzhen Jamr Technology Co., Ltd.Blood Pressure Monitor (W06LT) 摘要
K2540482026-05-14Shenzhen Urion Technology Co., Ltd.Wrist Watch Electronic Blood Pressure Monitor (U16H, 摘要
K2531522026-05-06Biozen, LLCBP1000 Ultra-Compact Fingertip Blood Pressure Monito 摘要
K2525012026-04-28Joytech Healthcare Co. , Ltd.Arm-type Fully Automatic Digital Blood Pressure Moni 摘要
K2602602026-04-28Honsun (Nantong) Co., Ltd.Automatic Digital Blood Pressure Monitor (LD-587, LD 摘要
K2539822026-04-21Beijing Hanvon Health Technology Co., Korotkoff sound blood pressure monitor 摘要
K2602762026-04-01Shenzhen AOJ Medical Technology Co., LArm Blood Pressure Monitor Models: ARM-30C+; ARM-30M
K2542252026-04-01Shenzhen HanHan Technology Co., Ltd.Arm Blood Pressure Monitor (HH-802CB, HH-802EB, HH-8 摘要
K2602732026-03-26Shenzhen Urion Technology Co., Ltd.Automatic Electronic Blood Pressure Monitor (U90B se 摘要
K2527792026-03-05Jiangsu Yuyue Medical Equipment & SuppYUWELL® Electronic Blood Pressure Monitor (YE630CR) 摘要
K2532282026-02-23Jiangsu Yuyue Medical Equipment & SuppYUWELL® Electronic Blood Pressure Monitor (YE650AR) 摘要
K2531332026-02-13Shenzhen Imdk Medical Technology Co., Wrist Blood Pressure Monitor (BPM-W1VL) 摘要
K2515812026-02-13Shenzhen Hingmed Medical Instrument CoWearable Ambulatory Blood Pressure Monitor (WBP-02A) 摘要
K2526852026-02-13Joytech Healthcare Co. , Ltd.Arm-type Fully Automatic Digital Blood Pressure Moni 摘要
K2513072026-01-12Shenzhen Hingmed Medical Instrument CoClinical Automatic Blood Pressure Monitor (DBP-20,DB 摘要
K2531422026-01-09Ningbo Ranor Medical Technology Co., LArm Blood Pressure Monitor (MJ1D,MJ1DS,MJ3D,MJ5D,MJ6 摘要
K2511432025-12-19Ningbo Ranor Medical Science & TechnolArm Blood Pressure Monitor (MJ1L, MJ2L, RN3L, RN4L,R 摘要
K2513312025-10-27Shenzhen Jamr Technology Co., Ltd.Blood Pressure Monitor (B73, BE23T) 摘要
K2517952025-10-09Honsun (Nantong) Co., Ltd.Wrist automatic blood pressure monitor (LD-735, LD-7 摘要
K2527692025-10-02Shenzhen Finicare Co., Ltd.Upper Arm Electronic Blood Pressure Monitor (FC-BP10 摘要
K2502312025-09-03Dongguan E-Test Technology Co., Ltd.Automatic Upper Arm Blood Pressure Monitor (BA-831X 摘要
K2511202025-08-06Microlife CorporationMicrolife Upper Arm Automatic Digital Blood Pressure 摘要
K2511132025-08-04Andon Health Co, Ltd.iHealth Compare Wireless Blood Pressure Monitor(BP-3 摘要
K2440072025-07-30Cardio Ring Technologies, Inc. Taiwan ArteVu 摘要
K2511022025-07-16Cemho Medical Technology (Guangdong) CAutomatic Blood Pressure Monitor (CH-S691L, CH-B607, 摘要
K2501852025-07-14Jiangxi Aicare Medical Technology Co.,Electronic Sphygmomanometers (ZH-X9, ZH-X12, ZH-X16, 摘要
K2504152025-07-02Aktiia SAG0 Blood Pressure Monitoring System (G0) 摘要
K2505482025-06-26Joytech Healthcare Co. , Ltd.Arm-type Fully Automatic Digital Blood Pressure Moni 摘要
K2501612025-05-02Shenzhen AOJ Medical Technology Co., LWrist Blood Pressure Monitor (AOJ-35A); Wrist Blood 摘要
K2440002025-04-30Shenzhen AOJ Medical Technology Co., LArm Blood Pressure Monitor (ARM-30A+);Arm Blood Pres 摘要
K2501162025-04-24Shenzhen AOJ Medical Technology Co., LArm Blood Pressure Monitor (ARM-30H); Arm Blood Pres 摘要
K2501362025-04-08Globalcare Medical Technology Co., LtdGlobalcare Blood Pressure Monitor (GUS610) 摘要
K2500912025-03-14Korot Co., Ltd.KOROT Blood Pressure Monitor (KOROT P3 Accurate) 摘要
K2431152025-02-21Shenzhen Urion Technology Co., Ltd.Upper Arm Electronic Blood Pressure Monitor (U87Y se 摘要
K2415782025-02-19Shenzhen Bsx Technology Electronics CoWrist Digital Blood Pressure Monitor (BSX312, BSX313 摘要
K2416342025-02-11Guangdong Xinyu Electronic and TechnolWrist Blood Pressure Monitor (XY-W01A, XY-W01B) 摘要
K2436612025-02-07Hetaida Technology Co., Ltd.Electronic Blood Pressure Monitor 摘要
K2423522025-02-05Accurate Meditech, Inc.Accurate Mini Non-invasive blood pressure monitor (A 摘要
K2415902025-02-03Guangdong Xinyu Electronic and TechnolArm Blood Pressure Monitor (XY-B01, XY-B02, XY-B03, 摘要
K2425682025-01-30Shenzhen Zhongkemingwang TelecommunicaWrist Blood Pressure Monitor (OHMS11, OHMS12) 摘要
K2417282025-01-23Murata Vios, Inc.Vios Monitoring System(TM) Model 2050; Vios Central 摘要
K2410662025-01-14Biobeat Technologies , Ltd.BB-613-BPM 摘要
K2414312025-01-13Joytech Healthcare Co. , Ltd.Arm-type Fully Automatic Digital Blood Pressure Moni 摘要
K2425282025-01-10Shenzhen Ruiankang Technology Co., LtdBlood Pressure Monitor (RAK260, RAK262, RAK263, RAK2 摘要
K2431182024-11-26Shenzhen Imdk Medical Technology Co., Arm Blood Pressure Monitor (model: BPM-A7VL) 摘要
K2410072024-10-24Shenzhen Urion Technology Co., Ltd.Upper Arm Electronic Blood Pressure Monitor (U86E an 摘要
K2421932024-10-22Avita CorporationArm Type Blood Pressure Monitor (BPM82) 摘要
K2416132024-10-16Shenzhen Hbcare Technology Co.,LtdElecrtronic Blood Pressure Monitor (BP-201, BP-202, 摘要
K2427212024-10-04Shenzhen Finicare Co., Ltd.Upper Arm Electronic Blood Pressure Monitor (FC-BP10 摘要
K2413512024-08-21Guangdong Transtek Medical ElectronicsBlood Pressure Monitor (TMB-2092-G) 摘要
K2411292024-07-03Shenzhen Goodlymed Technology Co., LtdUpper Arm Electronic Blood Pressure Monitor 摘要
K2407292024-06-14Shenzhen Pango Medical Electronics Co.Electronic Blood Pressure Monitor (Model: PG-800B30, 摘要
K2408322024-06-07Guangdong Transtek Medical ElectronicsBlood Pressure Monitor (BBZ32-AA01) 摘要
K2402542024-05-31Guangdong Transtek Medical ElectronicsBlood Pressure Monitor (TMB-2296-BT) 摘要
K2401022024-04-29Guangdong Transtek Medical ElectronicsBlood Pressure Monitor (TMB-2287-B) 摘要
K2340412024-04-22Andon Health Co, Ltd.Fully Automatic Electronic Blood Pressure Monitor (K 摘要
K2319842024-03-26Shenzhen Hingmed Medical Instrument CoClinical Automatic Blood Pressure Monitor (DBP-01P,D 摘要
K2331462024-03-19Shenzhen Jamr Technology Co., Ltd.Blood Pressure Monitor
K2337992024-03-15Shenzhen Yuezhongxing Technology Co., Wrist Blood Pressure Monitor (222); Wrist Blood Pres 摘要
K2313032024-01-26Joytech Healthcare Co. , Ltd.Arm-type Fully Automatic Digital Blood Pressure Moni 摘要
K2309962024-01-04Pursuant HealthPursuant Health Kiosk (G1.D5)
K2331302023-12-20Guangdong Transtek Medical ElectronicsBlood Pressure Monitor 摘要
K2314782023-12-15Wenzhou Yosun Medical Technology Co.,LDigital Blood Pressure Monitor (Model: YB-800) 摘要
K2328152023-12-11Zhuhai Yueja Medical Device TechnologyWrist Blood Pressure Monitor 摘要
K2320532023-12-08Nanowear, Inc.SimpleSense-BP, SimpleSense-BP Software Application 摘要
K2231702023-12-05Hetaida Technology Co., Ltd.Electronic Blood Pressure Monitor, model: HTD6602US 摘要
K2328142023-12-05Zhuhai Yueja Medical Device TechnologyElectronic Blood Pressure Monitor 摘要
K2327132023-11-28Guangdong Transtek Medical ElectronicsBlood Pressure Monitor 摘要
K2312502023-11-28Guangdong Genial Technology Co., Ltd.Digital Blood Pressure Monitor
K2312452023-11-22Guangdong Genial Technology Co., Ltd.Digital Blood Pressure Monitor (Arm Type)
K2326212023-11-22Guangdong Transtek Medical ElectronicsBlood pressure monitor 摘要
K2313102023-10-27Shenzhen Jumper Medical Equipment Co.,Electronic Blood Pressure Monitor 摘要
K2309192023-10-24Edwards Lifesciences, LLCAcumen IQ finger cuff 摘要
K2310502023-10-11Alicn Medical Shenzhen, Inc.Arm Blood Pressure Monitor
K2238732023-09-29Pyrames, Inc.Boppli Infant Blood Pressure Monitor 摘要
K2313672023-09-18Shenzhen Finicare Co., Ltd.Wrist Electronic Blood Pressure Monitor(Model FC-BP2 摘要
FDA 官方分类页： DXN
分类与上市路径以 FDA 现行公告为准。本页数据来自 openFDA（CC0 公有领域），不构成注册策略建议。