FDA 510(k)

Smart Set

Número K: K151250 · 2016-06-07

Data da decisão2016-06-07

Código do produtoFPA

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Smart Set is the device name listed in this FDA 510(k) record. The listed applicant is Top Spins, Inc.. It received FDA 510(k) clearance on 2016-06-07 under 510(k) number K151250. 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 Smart Set?

Smart Set is a medical device that received FDA 510(k) clearance on 2016-06-07. The listed applicant is Top Spins, Inc.. The 510(k) number is K151250.

When did Smart Set receive FDA 510(k) clearance?

Smart Set received FDA 510(k) clearance on 2016-06-07, under 510(k) number K151250.

Who is the listed applicant for Smart Set?

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

What is the FDA product code for Smart Set?

The FDA product code for Smart Set is FPA.

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