FDA 510(k)

Panoramic Oxygen Mask (POM)

Número K: K172365 · 2018-04-19

Data da decisão2018-04-19

Código do produtoCCK

Comité consultivoAN

DecisãoSubstantially Equivalent

Resumo do dispositivo

Panoramic Oxygen Mask (POM) is the device name listed in this FDA 510(k) record. The listed applicant is Pom Medical, LLC. It received FDA 510(k) clearance on 2018-04-19 under 510(k) number K172365. 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 Panoramic Oxygen Mask (POM)?

Panoramic Oxygen Mask (POM) is a medical device that received FDA 510(k) clearance on 2018-04-19. The listed applicant is Pom Medical, LLC. The 510(k) number is K172365.

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

Panoramic Oxygen Mask (POM) received FDA 510(k) clearance on 2018-04-19, under 510(k) number K172365.

Who is the listed applicant for Panoramic Oxygen Mask (POM)?

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

What is the FDA product code for Panoramic Oxygen Mask (POM)?

The FDA product code for Panoramic Oxygen Mask (POM) is CCK.

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