FDA 510(k)

Digital Thermometer, Model: DT007, DT008

Número K: K214077 · 2023-01-20

RequerenteGuangzhou Berrcom Medical Device Co., Ltd.

Data da decisão2023-01-20

Código do produtoFLL

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Digital Thermometer, Model: DT007, DT008 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 2023-01-20 under 510(k) number K214077. 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 Digital Thermometer, Model: DT007, DT008?

Digital Thermometer, Model: DT007, DT008 is a medical device that received FDA 510(k) clearance on 2023-01-20. The listed applicant is Guangzhou Berrcom Medical Device Co., Ltd.. The 510(k) number is K214077.

When did Digital Thermometer, Model: DT007, DT008 receive FDA 510(k) clearance?

Digital Thermometer, Model: DT007, DT008 received FDA 510(k) clearance on 2023-01-20, under 510(k) number K214077.

Who is the listed applicant for Digital Thermometer, Model: DT007, DT008?

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 Digital Thermometer, Model: DT007, DT008?

The FDA product code for Digital Thermometer, Model: DT007, DT008 is FLL.

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

K213746Digital thermometer, Model DT101, DT102 K213084Ear Thermometer, Model ET005, ET008, ET009 K213079Ear Thermometer, Model ET001 K213082Non-contact Infrared Thermometer, Models JXB-315, JXB-319, JXB-320, JXB-311 K191570Infrared Thermometer Model MD-H30

Dispositivos Relacionados (Código: FLL)

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Fonte oficial

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