FDA 510(k)

NOVA Patient Warming System

Número K: K203085 · 2020-11-12

Data da decisão2020-11-12

Código do produtoDWJ

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

NOVA Patient Warming System is the device name listed in this FDA 510(k) record. The listed applicant is Encompass Group, LLC. It received FDA 510(k) clearance on 2020-11-12 under 510(k) number K203085. The device is classified under product code DWJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the NOVA Patient Warming System?

NOVA Patient Warming System is a medical device that received FDA 510(k) clearance on 2020-11-12. The listed applicant is Encompass Group, LLC. The 510(k) number is K203085.

When did NOVA Patient Warming System receive FDA 510(k) clearance?

NOVA Patient Warming System received FDA 510(k) clearance on 2020-11-12, under 510(k) number K203085.

Who is the listed applicant for NOVA Patient Warming System?

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

What is the FDA product code for NOVA Patient Warming System?

The FDA product code for NOVA Patient Warming System is DWJ.

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