FDA 510(k)

BRS Procedure Face Mask

K-Number: K202824 · 2021-03-25

ApplicantBlackbriar Regulatory Services, LLC

Decision Date2021-03-25

Product CodeFXX

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

BRS Procedure Face Mask is a medical device manufactured by Blackbriar Regulatory Services, LLC. It received FDA 510(k) clearance on 2021-03-25 under approval number K202824. 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 BRS Procedure Face Mask?

BRS Procedure Face Mask is a medical device that received FDA 510(k) clearance on 2021-03-25. It is manufactured by Blackbriar Regulatory Services, LLC. The 510(k) number is K202824.

When was BRS Procedure Face Mask approved by the FDA?

BRS Procedure Face Mask received FDA 510(k) clearance on 2021-03-25, under approval number K202824.

What company makes BRS Procedure Face Mask?

BRS Procedure Face Mask is manufactured by Blackbriar Regulatory Services, LLC.

What is the FDA product code for BRS Procedure Face Mask?

The FDA product code for BRS Procedure Face Mask 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.