FDA 510(k)

Infrared Thermometer, model: PC808

Número K: K190717 · 2019-12-13

RequerenteShenzhen Pacom Medical Instruments Co., Ltd.

Data da decisão2019-12-13

Código do produtoFLL

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Infrared Thermometer, model: PC808 is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Pacom Medical Instruments Co., Ltd.. It received FDA 510(k) clearance on 2019-12-13 under 510(k) number K190717. 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 Infrared Thermometer, model: PC808?

Infrared Thermometer, model: PC808 is a medical device that received FDA 510(k) clearance on 2019-12-13. The listed applicant is Shenzhen Pacom Medical Instruments Co., Ltd.. The 510(k) number is K190717.

When did Infrared Thermometer, model: PC808 receive FDA 510(k) clearance?

Infrared Thermometer, model: PC808 received FDA 510(k) clearance on 2019-12-13, under 510(k) number K190717.

Who is the listed applicant for Infrared Thermometer, model: PC808?

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

What is the FDA product code for Infrared Thermometer, model: PC808?

The FDA product code for Infrared Thermometer, model: PC808 is FLL.

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Outros registros que listam Shenzhen Pacom Medical Instruments Co., Ltd. como candidato(a)

K172889Infrared Thermometer

Dispositivos Relacionados (Código: FLL)

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