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FDA 510(k)

Pure Tilt

N.º K: K152021 · 2016-03-31

SolicitanteProactive Comfort, LLC
Fecha de decisión2016-03-31
Código de productoIOR
Comité asesorPM
DecisiónSubstantially Equivalent

Resumen del dispositivo

Pure Tilt is the device name listed in this FDA 510(k) record. The listed applicant is Proactive Comfort, LLC. It received FDA 510(k) clearance on 2016-03-31 under 510(k) number K152021. The device is classified under product code IOR. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Pure Tilt?

Pure Tilt is a medical device that received FDA 510(k) clearance on 2016-03-31. The listed applicant is Proactive Comfort, LLC. The 510(k) number is K152021.

When did Pure Tilt receive FDA 510(k) clearance?

Pure Tilt received FDA 510(k) clearance on 2016-03-31, under 510(k) number K152021.

Who is the listed applicant for Pure Tilt?

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

What is the FDA product code for Pure Tilt?

The FDA product code for Pure Tilt is IOR.

Dispositivos relacionados (Código: IOR)

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Fuente oficial

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Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.

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