Medical Face Mask
K-Number: K211062 · 2021-06-08
Decision Date2021-06-08
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Medical Face Mask is a medical device manufactured by Ammex-Weida (Hubei) Health and Safety Products Co., Ltd.. It received FDA 510(k) clearance on 2021-06-08 under approval number K211062. 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 Medical Face Mask?
Medical Face Mask is a medical device that received FDA 510(k) clearance on 2021-06-08. It is manufactured by Ammex-Weida (Hubei) Health and Safety Products Co., Ltd.. The 510(k) number is K211062.
When was Medical Face Mask approved by the FDA?
Medical Face Mask received FDA 510(k) clearance on 2021-06-08, under approval number K211062.
What company makes Medical Face Mask?
Medical Face Mask is manufactured by Ammex-Weida (Hubei) Health and Safety Products Co., Ltd..
What is the FDA product code for Medical Face Mask?
The FDA product code for Medical Face Mask is FXX.
Other Devices by Ammex-Weida (Hubei) Health and Safety Products Co., 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.