FDA 510(k)

INFRARED EAR THERMOMETER, ET-100 SERIES

K-Number: K041692 · 2004-09-13

ApplicantHangzhou Hua'An Medical & Health Instruments Co.,

Decision Date2004-09-13

Product CodeFLL

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

INFRARED EAR THERMOMETER, ET-100 SERIES is the device name listed in this FDA 510(k) record. The listed applicant is Hangzhou Hua'An Medical & Health Instruments Co.,. It received FDA 510(k) clearance on 2004-09-13 under 510(k) number K041692. 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 INFRARED EAR THERMOMETER, ET-100 SERIES?

INFRARED EAR THERMOMETER, ET-100 SERIES is a medical device that received FDA 510(k) clearance on 2004-09-13. The listed applicant is Hangzhou Hua'An Medical & Health Instruments Co.,. The 510(k) number is K041692.

When did INFRARED EAR THERMOMETER, ET-100 SERIES receive FDA 510(k) clearance?

INFRARED EAR THERMOMETER, ET-100 SERIES received FDA 510(k) clearance on 2004-09-13, under 510(k) number K041692.

Who is the listed applicant for INFRARED EAR THERMOMETER, ET-100 SERIES?

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

What is the FDA product code for INFRARED EAR THERMOMETER, ET-100 SERIES?

The FDA product code for INFRARED EAR THERMOMETER, ET-100 SERIES is FLL.

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

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Related Devices (Code: FLL)

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.