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FDA 510(k)

INFRARED BODY THERMOMETER (Model: YK-001)

Número K: K210118 · 2021-09-15

RequerenteLongnan Renzhong Medical Equipment Co., Ltd.
Data da decisão2021-09-15
Código do produtoFLL
Comité consultivoHO
DecisãoSubstantially Equivalent

Resumo do dispositivo

INFRARED BODY THERMOMETER (Model: YK-001) is the device name listed in this FDA 510(k) record. The listed applicant is Longnan Renzhong Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2021-09-15 under 510(k) number K210118. 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 BODY THERMOMETER (Model: YK-001)?

INFRARED BODY THERMOMETER (Model: YK-001) is a medical device that received FDA 510(k) clearance on 2021-09-15. The listed applicant is Longnan Renzhong Medical Equipment Co., Ltd.. The 510(k) number is K210118.

When did INFRARED BODY THERMOMETER (Model: YK-001) receive FDA 510(k) clearance?

INFRARED BODY THERMOMETER (Model: YK-001) received FDA 510(k) clearance on 2021-09-15, under 510(k) number K210118.

Who is the listed applicant for INFRARED BODY THERMOMETER (Model: YK-001)?

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

What is the FDA product code for INFRARED BODY THERMOMETER (Model: YK-001)?

The FDA product code for INFRARED BODY THERMOMETER (Model: YK-001) 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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