FDA 510(k)

Non-contact Infrared Thermometer, Models JXB-315, JXB-319, JXB-320, JXB-311

Número K: K213082 · 2022-01-28

RequerenteGuangzhou Berrcom Medical Device Co., Ltd.

Data da decisão2022-01-28

Código do produtoFLL

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Non-contact Infrared Thermometer, Models JXB-315, JXB-319, JXB-320, JXB-311 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 2022-01-28 under 510(k) number K213082. 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 Non-contact Infrared Thermometer, Models JXB-315, JXB-319, JXB-320, JXB-311?

Non-contact Infrared Thermometer, Models JXB-315, JXB-319, JXB-320, JXB-311 is a medical device that received FDA 510(k) clearance on 2022-01-28. The listed applicant is Guangzhou Berrcom Medical Device Co., Ltd.. The 510(k) number is K213082.

When did Non-contact Infrared Thermometer, Models JXB-315, JXB-319, JXB-320, JXB-311 receive FDA 510(k) clearance?

Non-contact Infrared Thermometer, Models JXB-315, JXB-319, JXB-320, JXB-311 received FDA 510(k) clearance on 2022-01-28, under 510(k) number K213082.

Who is the listed applicant for Non-contact Infrared Thermometer, Models JXB-315, JXB-319, JXB-320, JXB-311?

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 Non-contact Infrared Thermometer, Models JXB-315, JXB-319, JXB-320, JXB-311?

The FDA product code for Non-contact Infrared Thermometer, Models JXB-315, JXB-319, JXB-320, JXB-311 is FLL.

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

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Dispositivos Relacionados (Código: FLL)

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Fonte oficial

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