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FDA 510(k)

Electronic Thermometer (XHF2001, XHF2002)

Número K: K211352 · 2021-09-09

RequerentePutian Hanjiang Huafeng Plastic Co., Ltd.
Data da decisão2021-09-09
Código do produtoFLL
Comité consultivoHO
DecisãoSubstantially Equivalent

Resumo do dispositivo

Electronic Thermometer (XHF2001, XHF2002) is the device name listed in this FDA 510(k) record. The listed applicant is Putian Hanjiang Huafeng Plastic Co., Ltd.. It received FDA 510(k) clearance on 2021-09-09 under 510(k) number K211352. 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 Electronic Thermometer (XHF2001, XHF2002)?

Electronic Thermometer (XHF2001, XHF2002) is a medical device that received FDA 510(k) clearance on 2021-09-09. The listed applicant is Putian Hanjiang Huafeng Plastic Co., Ltd.. The 510(k) number is K211352.

When did Electronic Thermometer (XHF2001, XHF2002) receive FDA 510(k) clearance?

Electronic Thermometer (XHF2001, XHF2002) received FDA 510(k) clearance on 2021-09-09, under 510(k) number K211352.

Who is the listed applicant for Electronic Thermometer (XHF2001, XHF2002)?

The FDA 510(k) record lists Putian Hanjiang Huafeng Plastic Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Electronic Thermometer (XHF2001, XHF2002)?

The FDA product code for Electronic Thermometer (XHF2001, XHF2002) 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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