FDA 510(k)

SinuBand

Número K: K160101 · 2016-07-27

RequerenteBioinspire Technologies, Incorporated

Data da decisão2016-07-27

Código do produtoQJL

Comité consultivoEN

DecisãoSubstantially Equivalent

Resumo do dispositivo

SinuBand is the device name listed in this FDA 510(k) record. The listed applicant is Bioinspire Technologies, Incorporated. It received FDA 510(k) clearance on 2016-07-27 under 510(k) number K160101. The device is classified under product code QJL. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the SinuBand?

SinuBand is a medical device that received FDA 510(k) clearance on 2016-07-27. The listed applicant is Bioinspire Technologies, Incorporated. The 510(k) number is K160101.

When did SinuBand receive FDA 510(k) clearance?

SinuBand received FDA 510(k) clearance on 2016-07-27, under 510(k) number K160101.

Who is the listed applicant for SinuBand?

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

What is the FDA product code for SinuBand?

The FDA product code for SinuBand is QJL.

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