FDA 510(k)

Safety Blood Collection Device for Single Use

Número K: K170276 · 2017-12-11

RequerenteGemtier Medical (Shanghai), Inc.

Data da decisão2017-12-11

Código do produtoFMI

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Safety Blood Collection Device for Single Use is the device name listed in this FDA 510(k) record. The listed applicant is Gemtier Medical (Shanghai), Inc.. It received FDA 510(k) clearance on 2017-12-11 under 510(k) number K170276. 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 Safety Blood Collection Device for Single Use?

Safety Blood Collection Device for Single Use is a medical device that received FDA 510(k) clearance on 2017-12-11. The listed applicant is Gemtier Medical (Shanghai), Inc.. The 510(k) number is K170276.

When did Safety Blood Collection Device for Single Use receive FDA 510(k) clearance?

Safety Blood Collection Device for Single Use received FDA 510(k) clearance on 2017-12-11, under 510(k) number K170276.

Who is the listed applicant for Safety Blood Collection Device for Single Use?

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

What is the FDA product code for Safety Blood Collection Device for Single Use?

The FDA product code for Safety Blood Collection Device for Single Use is FMI.

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