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FDA 510(k)

ROKI Surgical Mask

K-Number: K214094 · 2022-02-24

ApplicantRoki Co., Ltd.
Decision Date2022-02-24
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ROKI Surgical Mask is a medical device manufactured by Roki Co., Ltd.. It received FDA 510(k) clearance on 2022-02-24 under approval number K214094. 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 ROKI Surgical Mask?

ROKI Surgical Mask is a medical device that received FDA 510(k) clearance on 2022-02-24. It is manufactured by Roki Co., Ltd.. The 510(k) number is K214094.

When was ROKI Surgical Mask approved by the FDA?

ROKI Surgical Mask received FDA 510(k) clearance on 2022-02-24, under approval number K214094.

What company makes ROKI Surgical Mask?

ROKI Surgical Mask is manufactured by Roki Co., Ltd..

What is the FDA product code for ROKI Surgical Mask?

The FDA product code for ROKI Surgical 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

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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