FDA 510(k)

Endoscopy Oxygen Mask

Número K: K220533 · 2022-11-16

RequerenteEngineered Medical Systems, Inc.

Data da decisão2022-11-16

Código do produtoCCK

Comité consultivoAN

DecisãoSubstantially Equivalent

Resumo do dispositivo

Endoscopy Oxygen Mask is the device name listed in this FDA 510(k) record. The listed applicant is Engineered Medical Systems, Inc.. It received FDA 510(k) clearance on 2022-11-16 under 510(k) number K220533. The device is classified under product code CCK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Endoscopy Oxygen Mask?

Endoscopy Oxygen Mask is a medical device that received FDA 510(k) clearance on 2022-11-16. The listed applicant is Engineered Medical Systems, Inc.. The 510(k) number is K220533.

When did Endoscopy Oxygen Mask receive FDA 510(k) clearance?

Endoscopy Oxygen Mask received FDA 510(k) clearance on 2022-11-16, under 510(k) number K220533.

Who is the listed applicant for Endoscopy Oxygen Mask?

The FDA 510(k) record lists Engineered Medical Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Endoscopy Oxygen Mask?

The FDA product code for Endoscopy Oxygen Mask is CCK.

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