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FDA 510(k)

wireless thermometer

Número K: K170769 · 2017-07-26

RequerenteEch (Changzhou) Medical Instrument Co., Ltd.
Data da decisão2017-07-26
Código do produtoFLL
Comité consultivoHO
DecisãoSubstantially Equivalent

Resumo do dispositivo

wireless thermometer is the device name listed in this FDA 510(k) record. The listed applicant is Ech (Changzhou) Medical Instrument Co., Ltd.. It received FDA 510(k) clearance on 2017-07-26 under 510(k) number K170769. 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 wireless thermometer?

wireless thermometer is a medical device that received FDA 510(k) clearance on 2017-07-26. The listed applicant is Ech (Changzhou) Medical Instrument Co., Ltd.. The 510(k) number is K170769.

When did wireless thermometer receive FDA 510(k) clearance?

wireless thermometer received FDA 510(k) clearance on 2017-07-26, under 510(k) number K170769.

Who is the listed applicant for wireless thermometer?

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

What is the FDA product code for wireless thermometer?

The FDA product code for wireless thermometer is FLL.

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Dispositivos Relacionados (Código: FLL)

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

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