FDA 510(k)

BAYLAB 3-Ply Surgical Mask (BEACON I)

K-Number: K212302 · 2021-12-07

Decision Date2021-12-07

Product CodeFXX

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

BAYLAB 3-Ply Surgical Mask (BEACON I) is a medical device manufactured by Baylab USA, LLC. It received FDA 510(k) clearance on 2021-12-07 under approval number K212302. The device is classified under product code FXX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

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. It is manufactured by Baylab USA, LLC. The 510(k) number is K212302.

When was BAYLAB 3-Ply Surgical Mask (BEACON I) approved by the FDA?

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

What company makes BAYLAB 3-Ply Surgical Mask (BEACON I)?

BAYLAB 3-Ply Surgical Mask (BEACON I) is manufactured by Baylab USA, LLC.

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.

Related Devices (Code: FXX)

K153409Protect U Guard Earloop and Tie-On Mask (Blue, White or Green)Protect U Guard, LLC K160269Surgical Face Masks (Ear loops and Tie-on)San-M Package Co., Ltd. K152197Skypro, SP01 MaskSkypro Medical Supplies Company K153496Disposable Surgical Face MaskXiantao Rayxin Medical Products Co., Ltd. K152561Communicator Surgical Facemask with Clear WindowPrestige Ameritech , Ltd. K171162Surgical Earloop Face Mask with Bottom Gap Shield and Surgical Tie-On Face Mask with Bottom Gap ShieldPrestige Ameritech

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.