ReDe Mask
K-Number: K161953 · 2017-02-17
ApplicantTereopneuma
Decision Date2017-02-17
Product CodePRK
Advisory CommitteeAN
DecisionSubstantially Equivalent
Device Summary
ReDe Mask is a medical device manufactured by Tereopneuma. It received FDA 510(k) clearance on 2017-02-17 under approval number K161953. The device is classified under product code PRK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the ReDe Mask?
ReDe Mask is a medical device that received FDA 510(k) clearance on 2017-02-17. It is manufactured by Tereopneuma. The 510(k) number is K161953.
When was ReDe Mask approved by the FDA?
ReDe Mask received FDA 510(k) clearance on 2017-02-17, under approval number K161953.
What company makes ReDe Mask?
ReDe Mask is manufactured by Tereopneuma.
What is the FDA product code for ReDe Mask?
The FDA product code for ReDe Mask is PRK.
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.