FDA 510(k)

Endure ETCO2/02 Nasal Cannula

Número K: K213767 · 2023-09-12

Data da decisão2023-09-12

Código do produtoCCK

Comité consultivoAN

DecisãoSubstantially Equivalent

Resumo do dispositivo

Endure ETCO2/02 Nasal Cannula is the device name listed in this FDA 510(k) record. The listed applicant is Endure Industries, Inc.. It received FDA 510(k) clearance on 2023-09-12 under 510(k) number K213767. 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 Endure ETCO2/02 Nasal Cannula?

Endure ETCO2/02 Nasal Cannula is a medical device that received FDA 510(k) clearance on 2023-09-12. The listed applicant is Endure Industries, Inc.. The 510(k) number is K213767.

When did Endure ETCO2/02 Nasal Cannula receive FDA 510(k) clearance?

Endure ETCO2/02 Nasal Cannula received FDA 510(k) clearance on 2023-09-12, under 510(k) number K213767.

Who is the listed applicant for Endure ETCO2/02 Nasal Cannula?

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

What is the FDA product code for Endure ETCO2/02 Nasal Cannula?

The FDA product code for Endure ETCO2/02 Nasal Cannula is CCK.

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