BASE4 Disposable Medical Mask
K-Number: K202069 · 2020-12-01
ApplicantBase4 Group, Inc.
Decision Date2020-12-01
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
BASE4 Disposable Medical Mask is a medical device manufactured by Base4 Group, Inc.. It received FDA 510(k) clearance on 2020-12-01 under approval number K202069. 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 BASE4 Disposable Medical Mask?
BASE4 Disposable Medical Mask is a medical device that received FDA 510(k) clearance on 2020-12-01. It is manufactured by Base4 Group, Inc.. The 510(k) number is K202069.
When was BASE4 Disposable Medical Mask approved by the FDA?
BASE4 Disposable Medical Mask received FDA 510(k) clearance on 2020-12-01, under approval number K202069.
What company makes BASE4 Disposable Medical Mask?
BASE4 Disposable Medical Mask is manufactured by Base4 Group, Inc..
What is the FDA product code for BASE4 Disposable Medical Mask?
The FDA product code for BASE4 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.