FDA 510(k)

BAYLAB 3-Ply Surgical Mask (BEACON I)

Número K: K212302 · 2021-12-07

Data da decisão2021-12-07

Código do produtoFXX

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

BAYLAB 3-Ply Surgical Mask (BEACON I) is the device name listed in this FDA 510(k) record. The listed applicant is Baylab USA, LLC. It received FDA 510(k) clearance on 2021-12-07 under 510(k) number K212302. 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 BAYLAB 3-Ply Surgical Mask (BEACON I)?

BAYLAB 3-Ply Surgical Mask (BEACON I) is a medical device that received FDA 510(k) clearance on 2021-12-07. The listed applicant is Baylab USA, LLC. The 510(k) number is K212302.

When did BAYLAB 3-Ply Surgical Mask (BEACON I) receive FDA 510(k) clearance?

BAYLAB 3-Ply Surgical Mask (BEACON I) received FDA 510(k) clearance on 2021-12-07, under 510(k) number K212302.

Who is the listed applicant for BAYLAB 3-Ply Surgical Mask (BEACON I)?

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

What is the FDA product code for BAYLAB 3-Ply Surgical Mask (BEACON I)?

The FDA product code for BAYLAB 3-Ply Surgical Mask (BEACON I) is FXX.

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