American-Made Surgical Mask
K-Number: K210101 · 2022-01-26
ApplicantArmbrust, Inc.
Decision Date2022-01-26
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
American-Made Surgical Mask is a medical device manufactured by Armbrust, Inc.. It received FDA 510(k) clearance on 2022-01-26 under approval number K210101. 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 American-Made Surgical Mask?
American-Made Surgical Mask is a medical device that received FDA 510(k) clearance on 2022-01-26. It is manufactured by Armbrust, Inc.. The 510(k) number is K210101.
When was American-Made Surgical Mask approved by the FDA?
American-Made Surgical Mask received FDA 510(k) clearance on 2022-01-26, under approval number K210101.
What company makes American-Made Surgical Mask?
American-Made Surgical Mask is manufactured by Armbrust, Inc..
What is the FDA product code for American-Made Surgical Mask?
The FDA product code for American-Made Surgical Mask is FXX.
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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.