FDA 510(k)

NIO-P

Número K: K160805 · 2016-06-23

Data da decisão2016-06-23

Código do produtoFMI

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

NIO-P is the device name listed in this FDA 510(k) record. The listed applicant is Waismed, Ltd.. It received FDA 510(k) clearance on 2016-06-23 under 510(k) number K160805. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the NIO-P?

NIO-P is a medical device that received FDA 510(k) clearance on 2016-06-23. The listed applicant is Waismed, Ltd.. The 510(k) number is K160805.

When did NIO-P receive FDA 510(k) clearance?

NIO-P received FDA 510(k) clearance on 2016-06-23, under 510(k) number K160805.

Who is the listed applicant for NIO-P?

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

What is the FDA product code for NIO-P?

The FDA product code for NIO-P is FMI.

Outros registros que listam Waismed, 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.

K211968NIO+ Adult K190538NIO-I

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