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FDA 510(k)

GroWell BT Hair Growth System (GW10042)

Número K: K242619 · 2024-12-02

RequerenteApira Science, Inc.
Data da decisão2024-12-02
Código do produtoOAP
Comité consultivoPM
DecisãoSubstantially Equivalent

Resumo do dispositivo

GroWell BT Hair Growth System (GW10042) is the device name listed in this FDA 510(k) record. The listed applicant is Apira Science, Inc.. It received FDA 510(k) clearance on 2024-12-02 under 510(k) number K242619. The device is classified under product code OAP. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the GroWell BT Hair Growth System (GW10042)?

GroWell BT Hair Growth System (GW10042) is a medical device that received FDA 510(k) clearance on 2024-12-02. The listed applicant is Apira Science, Inc.. The 510(k) number is K242619.

When did GroWell BT Hair Growth System (GW10042) receive FDA 510(k) clearance?

GroWell BT Hair Growth System (GW10042) received FDA 510(k) clearance on 2024-12-02, under 510(k) number K242619.

Who is the listed applicant for GroWell BT Hair Growth System (GW10042)?

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

What is the FDA product code for GroWell BT Hair Growth System (GW10042)?

The FDA product code for GroWell BT Hair Growth System (GW10042) is OAP.

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Dispositivos Relacionados (Código: OAP)

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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Fonte oficial

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