FDA 510(k)

Greiner Holdex

Número K: K160532 · 2016-11-03

Data da decisão2016-11-03

Código do produtoFMI

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Greiner Holdex is the device name listed in this FDA 510(k) record. The listed applicant is Greiner Bio-One Na, Inc.. It received FDA 510(k) clearance on 2016-11-03 under 510(k) number K160532. 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 Greiner Holdex?

Greiner Holdex is a medical device that received FDA 510(k) clearance on 2016-11-03. The listed applicant is Greiner Bio-One Na, Inc.. The 510(k) number is K160532.

When did Greiner Holdex receive FDA 510(k) clearance?

Greiner Holdex received FDA 510(k) clearance on 2016-11-03, under 510(k) number K160532.

Who is the listed applicant for Greiner Holdex?

The FDA 510(k) record lists Greiner Bio-One Na, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Greiner Holdex?

The FDA product code for Greiner Holdex is FMI.

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