FDA 510(k)

Aurelia Surgical Mask ASTM Level 1; Aurelia Surgical Mask ASTM Level 2

Número K: K231005 · 2023-12-05

RequerenteSupermax Healthcare Canada-Supermax Medical

Data da decisão2023-12-05

Código do produtoFXX

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Aurelia Surgical Mask ASTM Level 1; Aurelia Surgical Mask ASTM Level 2 is the device name listed in this FDA 510(k) record. The listed applicant is Supermax Healthcare Canada-Supermax Medical. It received FDA 510(k) clearance on 2023-12-05 under 510(k) number K231005. 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 Aurelia Surgical Mask ASTM Level 1; Aurelia Surgical Mask ASTM Level 2?

Aurelia Surgical Mask ASTM Level 1; Aurelia Surgical Mask ASTM Level 2 is a medical device that received FDA 510(k) clearance on 2023-12-05. The listed applicant is Supermax Healthcare Canada-Supermax Medical. The 510(k) number is K231005.

When did Aurelia Surgical Mask ASTM Level 1; Aurelia Surgical Mask ASTM Level 2 receive FDA 510(k) clearance?

Aurelia Surgical Mask ASTM Level 1; Aurelia Surgical Mask ASTM Level 2 received FDA 510(k) clearance on 2023-12-05, under 510(k) number K231005.

Who is the listed applicant for Aurelia Surgical Mask ASTM Level 1; Aurelia Surgical Mask ASTM Level 2?

The FDA 510(k) record lists Supermax Healthcare Canada-Supermax Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Aurelia Surgical Mask ASTM Level 1; Aurelia Surgical Mask ASTM Level 2?

The FDA product code for Aurelia Surgical Mask ASTM Level 1; Aurelia Surgical Mask ASTM Level 2 is FXX.

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Outros registros que listam Supermax Healthcare Canada-Supermax Medical como candidato(a)

K242502Aurelia Surgical Mask ASTM Level-3 (2130)

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