FDA 510(k)

Savvy Surgical Mask - Level 3

Número K: K230383 · 2023-03-06

Data da decisão2023-03-06

Código do produtoFXX

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Savvy Surgical Mask - Level 3 is the device name listed in this FDA 510(k) record. The listed applicant is Alg Health, LLC. It received FDA 510(k) clearance on 2023-03-06 under 510(k) number K230383. The device is classified under product code FXX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Savvy Surgical Mask - Level 3?

Savvy Surgical Mask - Level 3 is a medical device that received FDA 510(k) clearance on 2023-03-06. The listed applicant is Alg Health, LLC. The 510(k) number is K230383.

When did Savvy Surgical Mask - Level 3 receive FDA 510(k) clearance?

Savvy Surgical Mask - Level 3 received FDA 510(k) clearance on 2023-03-06, under 510(k) number K230383.

Who is the listed applicant for Savvy Surgical Mask - Level 3?

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

What is the FDA product code for Savvy Surgical Mask - Level 3?

The FDA product code for Savvy Surgical Mask - Level 3 is FXX.

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