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FDA 510(k)

Digital thermometer(with disposable thermometer cover)

K-Number: K172861 · 2017-12-19

ApplicantHangzhou Hua'An Medical&Health Instruments Co.,Ltd
Decision Date2017-12-19
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Digital thermometer(with disposable thermometer cover) is the device name listed in this FDA 510(k) record. The listed applicant is Hangzhou Hua'An Medical&Health Instruments Co.,Ltd. It received FDA 510(k) clearance on 2017-12-19 under 510(k) number K172861. The device is classified under product code FLL. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Digital thermometer(with disposable thermometer cover)?

Digital thermometer(with disposable thermometer cover) is a medical device that received FDA 510(k) clearance on 2017-12-19. The listed applicant is Hangzhou Hua'An Medical&Health Instruments Co.,Ltd. The 510(k) number is K172861.

When did Digital thermometer(with disposable thermometer cover) receive FDA 510(k) clearance?

Digital thermometer(with disposable thermometer cover) received FDA 510(k) clearance on 2017-12-19, under 510(k) number K172861.

Who is the listed applicant for Digital thermometer(with disposable thermometer cover)?

The FDA 510(k) record lists Hangzhou Hua'An Medical&Health Instruments Co.,Ltd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Digital thermometer(with disposable thermometer cover)?

The FDA product code for Digital thermometer(with disposable thermometer cover) is FLL.

Other records listing Hangzhou Hua'An Medical&Health Instruments Co.,Ltd as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K172870Infra-red ear thermometer model: ET-100A, ET-100B, ET-100D, ET-100E, ET-100G, ET-100I, ET-100JK160999Infra-red forehead thermometer

Related Devices (Code: FLL)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253162Temperature probes (T2252-PG); Temperature probes (TCMA-AG); Temperature probes (TCMA-PG); Temperature probes (TMQ-DAG); Temperature probes (THP-DAG)Unimed Medical Supplies, Inc.K251160Sterile temperature probe (Model: W0001ES, W0028ES, W0101FS-A, W0101FS-P, W0099LS, W0099FS, W0099PS)Shenzhen Med-Link Electronics Tech Co., Ltd.K250470Ear Thermometer (EAR-E101); Ear Thermometer (EAR-E102); Ear Thermometer (EAR-E103)Shenzhen AOJ Medical Technology Co., Ltd.K243000Reusable Temperature Probe (T1306, T2306, T3306, T4306); Disposable Temperature Probe (T5106, T6106)Shenzhen Medke Technology Co., Ltd.K250878YUWELL® Infrared Ear Thermometer (YHT100); YUWELL® Infrared Ear Thermometer (YHT107)Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.K243082Infrared ThermometerGuangzhou Daxin Health Technology Co., Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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