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FDA 510(k)

Reza Band, Reflux Band

N.º K: K173934 · 2018-04-13

SolicitanteSomna Therapeutics, LLC
Fecha de decisión2018-04-13
Código de productoPKA
Comité asesorEN
DecisiónSubstantially Equivalent

Resumen del dispositivo

Reza Band, Reflux Band is the device name listed in this FDA 510(k) record. The listed applicant is Somna Therapeutics, LLC. It received FDA 510(k) clearance on 2018-04-13 under 510(k) number K173934. The device is classified under product code PKA. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Reza Band, Reflux Band?

Reza Band, Reflux Band is a medical device that received FDA 510(k) clearance on 2018-04-13. The listed applicant is Somna Therapeutics, LLC. The 510(k) number is K173934.

When did Reza Band, Reflux Band receive FDA 510(k) clearance?

Reza Band, Reflux Band received FDA 510(k) clearance on 2018-04-13, under 510(k) number K173934.

Who is the listed applicant for Reza Band, Reflux Band?

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

What is the FDA product code for Reza Band, Reflux Band?

The FDA product code for Reza Band, Reflux Band is PKA.

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Fuente oficial

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