FDA 510(k)

HPR45i

Número K: K220725 · 2023-03-20

Data da decisão2023-03-20

Código do produtoGEI

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

HPR45i is the device name listed in this FDA 510(k) record. The listed applicant is F Care Systems USA, LLC. It received FDA 510(k) clearance on 2023-03-20 under 510(k) number K220725. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the HPR45i?

HPR45i is a medical device that received FDA 510(k) clearance on 2023-03-20. The listed applicant is F Care Systems USA, LLC. The 510(k) number is K220725.

When did HPR45i receive FDA 510(k) clearance?

HPR45i received FDA 510(k) clearance on 2023-03-20, under 510(k) number K220725.

Who is the listed applicant for HPR45i?

The FDA 510(k) record lists F Care Systems USA, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HPR45i?

The FDA product code for HPR45i is GEI.

Outros registros que listam F Care Systems USA, LLC como candidato(a)

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.

K253918Veineo System (00MEDRF4000TCUS 05CR45iT 06Pedal1St)K252704F Care RF System (00MEDRF4000US, 05RAFAELOPROBE, 05SPHERAPROBE, 06OUTPUTKAB, 06Pedal1St)K210077MED RF 4000

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Fonte oficial

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