FDA 510(k)

AG 100s

Número K: K180991 · 2018-10-12

Data da decisão2018-10-12

Código do produtoBSK

Comité consultivoAN

DecisãoSubstantially Equivalent

Resumo do dispositivo

AG 100s is the device name listed in this FDA 510(k) record. The listed applicant is Hospitech Respiration , Ltd.. It received FDA 510(k) clearance on 2018-10-12 under 510(k) number K180991. The device is classified under product code BSK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the AG 100s?

AG 100s is a medical device that received FDA 510(k) clearance on 2018-10-12. The listed applicant is Hospitech Respiration , Ltd.. The 510(k) number is K180991.

When did AG 100s receive FDA 510(k) clearance?

AG 100s received FDA 510(k) clearance on 2018-10-12, under 510(k) number K180991.

Who is the listed applicant for AG 100s?

The FDA 510(k) record lists Hospitech Respiration , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AG 100s?

The FDA product code for AG 100s is BSK.

Outros registros que listam Hospitech Respiration , Ltd. 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.

K221477AG100s K150157Sistema de Guarda Respiratória AnapnoGuard 100

Dispositivos Relacionados (Código: BSK)

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Fonte oficial

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