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FDA 510(k)

Ear Thermometer, Model ET005, ET008, ET009

K-Number: K213084 · 2022-02-25

ApplicantGuangzhou Berrcom Medical Device Co., Ltd.
Decision Date2022-02-25
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Ear Thermometer, Model ET005, ET008, ET009 is a medical device manufactured by Guangzhou Berrcom Medical Device Co., Ltd.. It received FDA 510(k) clearance on 2022-02-25 under approval number K213084. 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 Ear Thermometer, Model ET005, ET008, ET009?

Ear Thermometer, Model ET005, ET008, ET009 is a medical device that received FDA 510(k) clearance on 2022-02-25. It is manufactured by Guangzhou Berrcom Medical Device Co., Ltd.. The 510(k) number is K213084.

When was Ear Thermometer, Model ET005, ET008, ET009 approved by the FDA?

Ear Thermometer, Model ET005, ET008, ET009 received FDA 510(k) clearance on 2022-02-25, under approval number K213084.

What company makes Ear Thermometer, Model ET005, ET008, ET009?

Ear Thermometer, Model ET005, ET008, ET009 is manufactured by Guangzhou Berrcom Medical Device Co., Ltd..

What is the FDA product code for Ear Thermometer, Model ET005, ET008, ET009?

The FDA product code for Ear Thermometer, Model ET005, ET008, ET009 is FLL.

Other Devices by Guangzhou Berrcom Medical Device Co., Ltd.

K191570Infrared Thermometer Model MD-H30 K213746Digital thermometer, Model DT101, DT102 K213079Ear Thermometer, Model ET001 K213082Non-contact Infrared Thermometer, Models JXB-315, JXB-319, JXB-320, JXB-311 K214077Digital Thermometer, Model: DT007, DT008

Related Devices (Code: FLL)

K160306Cloud Smart ThermometerGuangzhou Bosma Technology Co, Ltd. K161728Microlife Digital Infrared Forehead Thermometer, Model FR1MN1-1Microfile Intellectual Property GmbH K161735Non-contact Forehead ThermometerShenzhen Dongdixin Technology Co., Ltd. K160816Infrared Thermometer (Model: LX-26E, LX-260TE, PRO LX-261E, LX-360, LX-361T, BW-CX10)Nexmed Technology Co., Ltd. K161211Digital ThermometerBiocare Asia Corporation , Ltd. K160802Infrared Forehead Thermometer, FT-100AHangzhou Universal Electronic Co., Ltd.

Official Source

View on FDA Database →

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

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