FDA 510(k)

Freedom Syringe

Número K: K161812 · 2017-03-27

Data da decisão2017-03-27

Código do produtoFMF

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Freedom Syringe is the device name listed in this FDA 510(k) record. The listed applicant is Procedure Products, Inc.. It received FDA 510(k) clearance on 2017-03-27 under 510(k) number K161812. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Freedom Syringe?

Freedom Syringe is a medical device that received FDA 510(k) clearance on 2017-03-27. The listed applicant is Procedure Products, Inc.. The 510(k) number is K161812.

When did Freedom Syringe receive FDA 510(k) clearance?

Freedom Syringe received FDA 510(k) clearance on 2017-03-27, under 510(k) number K161812.

Who is the listed applicant for Freedom Syringe?

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

What is the FDA product code for Freedom Syringe?

The FDA product code for Freedom Syringe is FMF.

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