FDA 510(k)

ZAPnea Oral Appliance

Número K: K173064 · 2019-03-08

Data da decisão2019-03-08

Código do produtoLRK

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

ZAPnea Oral Appliance is the device name listed in this FDA 510(k) record. The listed applicant is B. Fareid, Dds, PC. It received FDA 510(k) clearance on 2019-03-08 under 510(k) number K173064. The device is classified under product code LRK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the ZAPnea Oral Appliance?

ZAPnea Oral Appliance is a medical device that received FDA 510(k) clearance on 2019-03-08. The listed applicant is B. Fareid, Dds, PC. The 510(k) number is K173064.

When did ZAPnea Oral Appliance receive FDA 510(k) clearance?

ZAPnea Oral Appliance received FDA 510(k) clearance on 2019-03-08, under 510(k) number K173064.

Who is the listed applicant for ZAPnea Oral Appliance?

The FDA 510(k) record lists B. Fareid, Dds, PC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ZAPnea Oral Appliance?

The FDA product code for ZAPnea Oral Appliance is LRK.

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