FDA 510(k)

DELTAWAVE Nasal Pillows System

N.º K: K233415 · 2024-07-02

Fecha de decisión2024-07-02

Código de productoBZD

Comité asesorAN

DecisiónSubstantially Equivalent

Resumen del dispositivo

DELTAWAVE Nasal Pillows System is the device name listed in this FDA 510(k) record. The listed applicant is Remsleep Holdings. It received FDA 510(k) clearance on 2024-07-02 under 510(k) number K233415. The device is classified under product code BZD. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the DELTAWAVE Nasal Pillows System?

DELTAWAVE Nasal Pillows System is a medical device that received FDA 510(k) clearance on 2024-07-02. The listed applicant is Remsleep Holdings. The 510(k) number is K233415.

When did DELTAWAVE Nasal Pillows System receive FDA 510(k) clearance?

DELTAWAVE Nasal Pillows System received FDA 510(k) clearance on 2024-07-02, under 510(k) number K233415.

Who is the listed applicant for DELTAWAVE Nasal Pillows System?

The FDA 510(k) record lists Remsleep Holdings as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DELTAWAVE Nasal Pillows System?

The FDA product code for DELTAWAVE Nasal Pillows System is BZD.

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Fuente oficial

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