FDA 510(k)

Ear Thermometer, Model ET001

Número K: K213079 · 2022-02-18

RequerenteGuangzhou Berrcom Medical Device Co., Ltd.

Data da decisão2022-02-18

Código do produtoFLL

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Ear Thermometer, Model ET001 is the device name listed in this FDA 510(k) record. The listed applicant is Guangzhou Berrcom Medical Device Co., Ltd.. It received FDA 510(k) clearance on 2022-02-18 under 510(k) number K213079. The device is classified under product code FLL. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Ear Thermometer, Model ET001?

Ear Thermometer, Model ET001 is a medical device that received FDA 510(k) clearance on 2022-02-18. The listed applicant is Guangzhou Berrcom Medical Device Co., Ltd.. The 510(k) number is K213079.

When did Ear Thermometer, Model ET001 receive FDA 510(k) clearance?

Ear Thermometer, Model ET001 received FDA 510(k) clearance on 2022-02-18, under 510(k) number K213079.

Who is the listed applicant for Ear Thermometer, Model ET001?

The FDA 510(k) record lists Guangzhou Berrcom Medical Device Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Ear Thermometer, Model ET001?

The FDA product code for Ear Thermometer, Model ET001 is FLL.

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Outros registros que listam Guangzhou Berrcom Medical Device Co., Ltd. como candidato(a)

K214077Digital Thermometer, Model: DT007, DT008 K213746Digital thermometer, Model DT101, DT102 K213084Ear Thermometer, Model ET005, ET008, ET009 K213082Non-contact Infrared Thermometer, Models JXB-315, JXB-319, JXB-320, JXB-311 K191570Infrared Thermometer Model MD-H30

Dispositivos Relacionados (Código: 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.

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