Asept Surgical Face Mask
K-Number: K201137 · 2020-08-19
ApplicantPfm Medical, Inc.
Decision Date2020-08-19
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Asept Surgical Face Mask is a medical device manufactured by Pfm Medical, Inc.. It received FDA 510(k) clearance on 2020-08-19 under approval number K201137. 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 Asept Surgical Face Mask?
Asept Surgical Face Mask is a medical device that received FDA 510(k) clearance on 2020-08-19. It is manufactured by Pfm Medical, Inc.. The 510(k) number is K201137.
When was Asept Surgical Face Mask approved by the FDA?
Asept Surgical Face Mask received FDA 510(k) clearance on 2020-08-19, under approval number K201137.
What company makes Asept Surgical Face Mask?
Asept Surgical Face Mask is manufactured by Pfm Medical, Inc..
What is the FDA product code for Asept Surgical Face Mask?
The FDA product code for Asept Surgical Face Mask is FXX.
Other Devices by Pfm Medical, Inc.
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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.