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FDA 510(k)

Infrared Thermometer, Breeze model

Número K: K191283 · 2019-10-18

RequerenteSuzhou Melodicare Medical Technology Co., Ltd.
Data da decisão2019-10-18
Código do produtoFLL
Comité consultivoHO
DecisãoSubstantially Equivalent

Resumo do dispositivo

Infrared Thermometer, Breeze model is the device name listed in this FDA 510(k) record. The listed applicant is Suzhou Melodicare Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2019-10-18 under 510(k) number K191283. 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, Breeze model?

Infrared Thermometer, Breeze model is a medical device that received FDA 510(k) clearance on 2019-10-18. The listed applicant is Suzhou Melodicare Medical Technology Co., Ltd.. The 510(k) number is K191283.

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

Infrared Thermometer, Breeze model received FDA 510(k) clearance on 2019-10-18, under 510(k) number K191283.

Who is the listed applicant for Infrared Thermometer, Breeze model?

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

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

The FDA product code for Infrared Thermometer, Breeze model 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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