DemeMASK
K-Number: K201479 · 2020-07-24
ApplicantDemetech Corporation
Decision Date2020-07-24
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
DemeMASK is a medical device manufactured by Demetech Corporation. It received FDA 510(k) clearance on 2020-07-24 under approval number K201479. 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 DemeMASK?
DemeMASK is a medical device that received FDA 510(k) clearance on 2020-07-24. It is manufactured by Demetech Corporation. The 510(k) number is K201479.
When was DemeMASK approved by the FDA?
DemeMASK received FDA 510(k) clearance on 2020-07-24, under approval number K201479.
What company makes DemeMASK?
DemeMASK is manufactured by Demetech Corporation.
What is the FDA product code for DemeMASK?
The FDA product code for DemeMASK 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.