FDA 510(k)

Cool Renewal

N.º K: K161296 · 2016-07-06

Fecha de decisión2016-07-06

Código de productoGEH

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

Cool Renewal is the device name listed in this FDA 510(k) record. The listed applicant is Cool Renewal, LLC. It received FDA 510(k) clearance on 2016-07-06 under 510(k) number K161296. The device is classified under product code GEH. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Cool Renewal?

Cool Renewal is a medical device that received FDA 510(k) clearance on 2016-07-06. The listed applicant is Cool Renewal, LLC. The 510(k) number is K161296.

When did Cool Renewal receive FDA 510(k) clearance?

Cool Renewal received FDA 510(k) clearance on 2016-07-06, under 510(k) number K161296.

Who is the listed applicant for Cool Renewal?

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

What is the FDA product code for Cool Renewal?

The FDA product code for Cool Renewal is GEH.

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Fuente oficial

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