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FLL

Continuous Measurement Thermometer

产品代码
FLL
器械名称
Continuous Measurement Thermometer
管理类别
第 2 类(Class II)
21 CFR 条款
21 CFR 880.2910
FDA 专业组
General Hospital
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)
24 件
其中 Summary 已存档
18 份,可直接下载
FDA 历史累计 510(k)
798 件(全部年份;本站只收录近三年的明细)

FDA 分类定义

A continuous measurement thermometer is a clinical electronic thermometer indicated to measure the body or skin temperature of a person continuously or in specified intervals. Under this regulation, this product code represents non-exempt devices. For more information, see 90 FR 25889, available at https://www.govinfo.gov/content/pkg/FR-2025-06-18/pdf/2025-11207.pdf.

定义原文来自 FDA 器械分类库,属美国联邦政府作品(公有领域)。

该代码近三年的 510(k)(24 件)

数据窗口为最近三年。最新一件:2026-06-05。

510(k) 号批准日期申请人器械名称摘要
K2531622026-06-05Unimed Medical Supplies, Inc.Temperature probes (T2252-PG); Temperature probes (T…PDF
K2511602026-01-08Shenzhen Med-Link Electronics Tech Co.…Sterile temperature probe (Model: W0001ES, W0028ES, …PDF
K2504702025-06-23Shenzhen AOJ Medical Technology Co., L…Ear Thermometer (EAR-E101); Ear Thermometer (EAR-E10…PDF
K2430002025-06-20Shenzhen Medke Technology Co., Ltd.Reusable Temperature Probe (T1306, T2306, T3306, T43…PDF
K2508782025-05-22Jiangsu Yuyue Medical Equipment & Supp…YUWELL® Infrared Ear Thermometer (YHT100); YUWELL® I…PDF
K2430822025-04-25Guangzhou Daxin Health Technology Co.,…Infrared ThermometerPDF
K2504012025-03-14Aion Biosystems, Inc.AION TempShield™FDA
K2431362025-02-14Shenzhen Finicare Co., Ltd.Non-contact Forehead Infrared Thermometer (FC-IR2000…PDF
K2403332024-10-30Guangdong Genial Technology Co., Ltd.Wearable Digital Thermometer (T31)PDF
K2402232024-10-25Metko Medikal VE Tibbi Cihazlar Dis Ti…FMT Disposable and Autoclavable Temperature Probes—
K2402202024-09-27Taiwan Aulisa Medical Devices Technolo…Aulisa Temperature Module (TM0002)PDF
K2400772024-08-20CovidienMon-a-Therm™ General Purpose Temperature Probe 400TM…FDA
K2332802024-06-21Steadysense GmbHSteadyTempPDF
K2406482024-06-05Radiant Innovation, Inc.Non-contact Forehead Thermomete (TH48FE, TH09F, THD2…PDF
K2401092024-04-12Zhuzhou Goldenhot Medical Technology C…Medical electronic thermometer (FC01, FC02)PDF
K2331922024-04-05Famidoc Technology Company LimitedWireless Smart ThermometerPDF
K2308892024-04-03Wenzhou Yosun Medical Technology Co.,L…Digital Thermometer—
K2400232024-03-01Shenzhen YI Fang Blister Packaging Co.…Probe Covers (YF-001, YF-002)PDF
K2324732024-02-09Zhuhai Yueja Medical Device Technology…Infrared Thermometer: Model YJ600PDF
K2316252024-02-02Wellvii, Inc.VitalDetectPDF
K2326782024-01-31Guangdong Genial Technology Co., Ltd.Digital Thermometer, Model T28, T28L—
K2323382023-12-22Alicn Medical Shenzhen, Inc.Electronic Thermometer, Model: AET-F331, AET-F332, A…—
K2220572023-12-05T&R BIOFAB CO., Ltd.THERMOCLICKPDF
K2321282023-10-14Shenzhen AOJ Medical Technology Co., L…Infrared Thermometer (AOJ-20A); Infrared Thermometer…PDF

其中 18 件的 Summary 已存档在本站,点 PDF 直接下载;其余给 FDA 官方链接。

FDA 官方分类页: FLL
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。