FDA 510(k)

Encore Neutral

Número K: K162826 · 2017-06-15

Data da decisão2017-06-15

Código do produtoFPA

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Encore Neutral is the device name listed in this FDA 510(k) record. The listed applicant is Rymed Technologies, LLC. It received FDA 510(k) clearance on 2017-06-15 under 510(k) number K162826. The device is classified under product code FPA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Encore Neutral?

Encore Neutral is a medical device that received FDA 510(k) clearance on 2017-06-15. The listed applicant is Rymed Technologies, LLC. The 510(k) number is K162826.

When did Encore Neutral receive FDA 510(k) clearance?

Encore Neutral received FDA 510(k) clearance on 2017-06-15, under 510(k) number K162826.

Who is the listed applicant for Encore Neutral?

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

What is the FDA product code for Encore Neutral?

The FDA product code for Encore Neutral is FPA.

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