AOK 95A Medical Mask (20200049)
K-Number: K220876 · 2022-07-27
ApplicantAok Tooling Limited
Decision Date2022-07-27
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
AOK 95A Medical Mask (20200049) is a medical device manufactured by Aok Tooling Limited. It received FDA 510(k) clearance on 2022-07-27 under approval number K220876. 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 AOK 95A Medical Mask (20200049)?
AOK 95A Medical Mask (20200049) is a medical device that received FDA 510(k) clearance on 2022-07-27. It is manufactured by Aok Tooling Limited. The 510(k) number is K220876.
When was AOK 95A Medical Mask (20200049) approved by the FDA?
AOK 95A Medical Mask (20200049) received FDA 510(k) clearance on 2022-07-27, under approval number K220876.
What company makes AOK 95A Medical Mask (20200049)?
AOK 95A Medical Mask (20200049) is manufactured by Aok Tooling Limited.
What is the FDA product code for AOK 95A Medical Mask (20200049)?
The FDA product code for AOK 95A Medical Mask (20200049) 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.