FDA 510(k)

Aurelia Surgical Mask ASTM Level-3 (2130)

Número K: K242502 · 2024-11-12

RequerenteSupermax Healthcare Canada – Supermax Medical

Data da decisão2024-11-12

Código do produtoFXX

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Aurelia Surgical Mask ASTM Level-3 (2130) 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 2024-11-12 under 510(k) number K242502. 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-3 (2130)?

Aurelia Surgical Mask ASTM Level-3 (2130) is a medical device that received FDA 510(k) clearance on 2024-11-12. The listed applicant is Supermax Healthcare Canada – Supermax Medical. The 510(k) number is K242502.

When did Aurelia Surgical Mask ASTM Level-3 (2130) receive FDA 510(k) clearance?

Aurelia Surgical Mask ASTM Level-3 (2130) received FDA 510(k) clearance on 2024-11-12, under 510(k) number K242502.

Who is the listed applicant for Aurelia Surgical Mask ASTM Level-3 (2130)?

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-3 (2130)?

The FDA product code for Aurelia Surgical Mask ASTM Level-3 (2130) is FXX.

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

K231005Aurelia Surgical Mask ASTM Level 1; Aurelia Surgical Mask ASTM Level 2

Dispositivos Relacionados (Código: FXX)

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Fonte oficial

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