nPro Surgical Mask
K-Number: K203265 · 2021-02-09
ApplicantNp Medical, Inc.
Decision Date2021-02-09
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
nPro Surgical Mask is a medical device manufactured by Np Medical, Inc.. It received FDA 510(k) clearance on 2021-02-09 under approval number K203265. 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 nPro Surgical Mask?
nPro Surgical Mask is a medical device that received FDA 510(k) clearance on 2021-02-09. It is manufactured by Np Medical, Inc.. The 510(k) number is K203265.
When was nPro Surgical Mask approved by the FDA?
nPro Surgical Mask received FDA 510(k) clearance on 2021-02-09, under approval number K203265.
What company makes nPro Surgical Mask?
nPro Surgical Mask is manufactured by Np Medical, Inc..
What is the FDA product code for nPro Surgical Mask?
The FDA product code for nPro Surgical Mask is FXX.
Other Devices by Np 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.