Ear-Friendly Mask
K-Number: K211105 · 2021-05-17
ApplicantRay Co., Ltd.
Decision Date2021-05-17
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Ear-Friendly Mask is a medical device manufactured by Ray Co., Ltd.. It received FDA 510(k) clearance on 2021-05-17 under approval number K211105. 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 Ear-Friendly Mask?
Ear-Friendly Mask is a medical device that received FDA 510(k) clearance on 2021-05-17. It is manufactured by Ray Co., Ltd.. The 510(k) number is K211105.
When was Ear-Friendly Mask approved by the FDA?
Ear-Friendly Mask received FDA 510(k) clearance on 2021-05-17, under approval number K211105.
What company makes Ear-Friendly Mask?
Ear-Friendly Mask is manufactured by Ray Co., Ltd..
What is the FDA product code for Ear-Friendly Mask?
The FDA product code for Ear-Friendly Mask is FXX.
Other Devices by Ray Co., Ltd.
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K152197Skypro, SP01 MaskSkypro Medical Supplies Company
K153496Disposable Surgical Face MaskXiantao Rayxin Medical Products Co., Ltd.
K152561Communicator Surgical Facemask with Clear WindowPrestige Ameritech , Ltd.
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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.