AIC disposable medical mask
K-Number: K203775 · 2021-03-12
ApplicantThe Aleen International Corporation
Decision Date2021-03-12
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
AIC disposable medical mask is a medical device manufactured by The Aleen International Corporation. It received FDA 510(k) clearance on 2021-03-12 under approval number K203775. 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 AIC disposable medical mask?
AIC disposable medical mask is a medical device that received FDA 510(k) clearance on 2021-03-12. It is manufactured by The Aleen International Corporation. The 510(k) number is K203775.
When was AIC disposable medical mask approved by the FDA?
AIC disposable medical mask received FDA 510(k) clearance on 2021-03-12, under approval number K203775.
What company makes AIC disposable medical mask?
AIC disposable medical mask is manufactured by The Aleen International Corporation.
What is the FDA product code for AIC disposable medical mask?
The FDA product code for AIC disposable medical 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.