Classic
K-Number: K203477 · 2021-02-25
ApplicantOrthoapnea S.L.
Decision Date2021-02-25
Product CodeLRK
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Classic is a medical device manufactured by Orthoapnea S.L.. It received FDA 510(k) clearance on 2021-02-25 under approval number K203477. The device is classified under product code LRK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Classic?
Classic is a medical device that received FDA 510(k) clearance on 2021-02-25. It is manufactured by Orthoapnea S.L.. The 510(k) number is K203477.
When was Classic approved by the FDA?
Classic received FDA 510(k) clearance on 2021-02-25, under approval number K203477.
What company makes Classic?
Classic is manufactured by Orthoapnea S.L..
What is the FDA product code for Classic?
The FDA product code for Classic is LRK.
Other Devices by Orthoapnea S.L.
Related Devices (Code: LRK)
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.