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FDA 510(k)

NC° Thermometer (Gen 3), Model Number: NCTG3

Número K: K223522 · 2023-06-20

RequerenteXiamen Intretech, Inc.
Data da decisão2023-06-20
Código do produtoFLL
Comité consultivoHO
DecisãoSubstantially Equivalent

Resumo do dispositivo

NC° Thermometer (Gen 3), Model Number: NCTG3 is the device name listed in this FDA 510(k) record. The listed applicant is Xiamen Intretech, Inc.. It received FDA 510(k) clearance on 2023-06-20 under 510(k) number K223522. 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 NC° Thermometer (Gen 3), Model Number: NCTG3?

NC° Thermometer (Gen 3), Model Number: NCTG3 is a medical device that received FDA 510(k) clearance on 2023-06-20. The listed applicant is Xiamen Intretech, Inc.. The 510(k) number is K223522.

When did NC° Thermometer (Gen 3), Model Number: NCTG3 receive FDA 510(k) clearance?

NC° Thermometer (Gen 3), Model Number: NCTG3 received FDA 510(k) clearance on 2023-06-20, under 510(k) number K223522.

Who is the listed applicant for NC° Thermometer (Gen 3), Model Number: NCTG3?

The FDA 510(k) record lists Xiamen Intretech, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NC° Thermometer (Gen 3), Model Number: NCTG3?

The FDA product code for NC° Thermometer (Gen 3), Model Number: NCTG3 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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