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FDA 510(k)

M1 Surgical Face Mask

K-Number: K202457 · 2021-04-29

ApplicantCHISON Medical Technologies Co., Ltd.
Decision Date2021-04-29
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

M1 Surgical Face Mask is a medical device manufactured by CHISON Medical Technologies Co., Ltd.. It received FDA 510(k) clearance on 2021-04-29 under approval number K202457. 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 M1 Surgical Face Mask?

M1 Surgical Face Mask is a medical device that received FDA 510(k) clearance on 2021-04-29. It is manufactured by CHISON Medical Technologies Co., Ltd.. The 510(k) number is K202457.

When was M1 Surgical Face Mask approved by the FDA?

M1 Surgical Face Mask received FDA 510(k) clearance on 2021-04-29, under approval number K202457.

What company makes M1 Surgical Face Mask?

M1 Surgical Face Mask is manufactured by CHISON Medical Technologies Co., Ltd..

What is the FDA product code for M1 Surgical Face Mask?

The FDA product code for M1 Surgical Face Mask is FXX.

Other Devices by CHISON Medical Technologies Co., Ltd.

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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

View on FDA Database →

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

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