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DQA

Oximeter

产品代码
DQA
器械名称
Oximeter
管理类别
第 2 类（Class II）
21 CFR 条款
21 CFR 870.2700
FDA 专业组
Cardiovascular
上市路径
需提交 510(k) 上市前通告
该代码近三年的 510(k)
726 件

该代码近三年的 510(k)（40 件）

数据窗口为最近三年。最新一件：2026-05-29。

510(k) 号批准日期申请人器械名称
K2528212026-05-29Philips Medizin Systeme Böblingen GmbHReusable Adult SpO2 Clip Sensor (3m) (M1196A); Reusa 摘要
K2526552026-05-11Shenzhen Imdk Medical Technology Co., Pulse Oximeter (PO-A2AO, PO-A2AT, PO-A3AO, PO-H1AO, 摘要
K2538872026-05-01Philips Medizin SystemeNasal Alar SpO2 Sensor (989803205381); Nasal Alar Sp 摘要
K2609312026-04-14Unimed Medical Supplies, Inc.Unimed Reusable Finger Clip SpO2 Sensors (U403-49R a 摘要
K2524482026-02-27Avita CorporationAViTA Pulse Oximeter (SP61) 摘要
K2528052026-02-17Jiangsu Yuyue Medical Equipment & SuppYUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, 摘要
K2531092026-01-07Shenzhen Best Electronics Co., Ltd.Reusable SPO2 Sensor (BSA307-47; BSA109-50; BSA109-3 摘要
K2517512025-12-19Shenzhen Ykd Technology Co., Ltd.Spo2 Sensor CSS032D 摘要
K2516962025-12-01Unimed Medical Supplies, Inc.Unimed Reusable SpO2 Sensors (-48 Series and -29 Ser 摘要
K2516912025-12-01Unimed Medical Supplies, Inc.Unimed Reusable SpO2 Sensors (-08 Series) (U403S-08) 摘要
K2516932025-11-18Unimed Medical Supplies, Inc.Unimed Reusable SpO2 Sensors (-75 Series) (U410-75); 摘要
K2516952025-11-18Unimed Medical Supplies, Inc.Unimed Reusable SpO2 Sensors (-06 Series) (U403S-06) 摘要
K2508372025-09-25Shanghai Berry Electronic Tech Co., LtPulse Oximeter 摘要
K2509312025-08-13Unimed Medical Supplies, Inc.Unimed Reusable SpO2 Sensors (-117 and -121 Series) 摘要
K2410862025-05-09Avidhrt, Inc.Avidhrt Sense SpO2 摘要
K2428762025-02-28Shenzhen Viatom Technology Co., Ltd.Pulse Oximeter ( PO2, PO2A, PO2B) 摘要
K2339632025-02-25Taiwan Aulisa Medical Devices TechnoloAulisa Oximeter Module (2nd Gen.) (GA-OM0007, GA-OM0 摘要
K2430862025-02-20Unimed Medical Supplies, Inc.Unimed Reusable Finger Clip SpO2 Sensors (UXXX-91 Se 摘要
K2424552025-02-19Avita CorporationAViTA Pulse Oximeter (SP62B) 摘要
K2425802025-02-06Unimed Medical Supplies, Inc.Unimed Reusable Finger Clip SpO2 Sensors (U103-125); 摘要
K2339562025-01-30Taiwan Aulisa Medical Devices TechnoloAulisa Infant Oximeter Module (2nd Gen.) (GA-OM0018) 摘要
K2430492025-01-02Hunan Accurate Bio-Medical Technology Pulse Oximeter (FS20P); Pulse Oximeter (FS20C); Puls 摘要
K2410902024-11-29Movano Inc. Dba Movano HealthEvie Med Ring 摘要
K2325202024-11-21Shenzhen Smallsignal Technology Co., LFingertip Pulse Oximeter, models Alpine20, Alpine20A 摘要
K2400922024-10-25Shenzhen Yimi Life Technology Co., LtdPulse Oximeter (YM101, YM102, YM103, YM104, YM201, Y 摘要
K2341102024-10-11Belun Technology Company LimitedBelun Ring BLR-200 (BLR-200) 摘要
K2408082024-10-03Hunan Accurate Bio-Medical Technology Pulse Oximeter (WS20A) 摘要
K2338272024-08-28Oxiwear, Inc.OxiWear 摘要
K2319792024-08-16Shenzhen Mecun Medical Supply Co., LtdMecun SpO2 sensor 摘要
K2329892024-07-01Shenzhen AOJ Medical Technology Co., LPulse Oximeter (AOJ-70A); Pulse Oximeter (AOJ-70B); 摘要
K2329752024-06-21Beijing Choice Electronic Technology CPulse Oximeter (MD300C228) 摘要
K2403052024-05-28Sibel Health, Inc.ANNE Limb 摘要
K2233992024-05-20Avita CorporationAViTA Pulse Oximeter 摘要
K2324952024-05-16Sempulse CorporationSempulse Halo Vital Signs Monitor
K2312882024-03-04Vyvo Technology Corp.(Vt)Vyvo 摘要
K2302772024-01-04Cofoe Medical Technology Co., Ltd.Pulse Oximeter(Model OHT60,OXH78) 摘要
K2315312023-12-21Hinlab, Inc.Pediarity™ 摘要
K2237212023-12-15Masimo CorporationMasimo Stork 摘要
K2305872023-11-30Beijing Choice Electronic Technology CWrist Pulse Oximeter 摘要
K2312432023-10-31Guangdong Genial Technology Co., Ltd.Finger Clip Pulse Oximeter
FDA 官方分类页： DQA
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。