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FDA 510(k)

Livocare Surgical Mask

K-Number: K201380 · 2020-10-07

ApplicantAndon Health Co, Ltd.
Decision Date2020-10-07
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Livocare Surgical Mask is a medical device manufactured by Andon Health Co, Ltd.. It received FDA 510(k) clearance on 2020-10-07 under approval number K201380. 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 Livocare Surgical Mask?

Livocare Surgical Mask is a medical device that received FDA 510(k) clearance on 2020-10-07. It is manufactured by Andon Health Co, Ltd.. The 510(k) number is K201380.

When was Livocare Surgical Mask approved by the FDA?

Livocare Surgical Mask received FDA 510(k) clearance on 2020-10-07, under approval number K201380.

What company makes Livocare Surgical Mask?

Livocare Surgical Mask is manufactured by Andon Health Co, Ltd..

What is the FDA product code for Livocare Surgical Mask?

The FDA product code for Livocare Surgical Mask is FXX.

Other Devices by Andon Health 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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