Aniti-Snore Mouthguard+
K-Number: K231138 · 2024-01-16
ApplicantOscimed SA
Decision Date2024-01-16
Product CodeLRK
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Aniti-Snore Mouthguard+ is a medical device manufactured by Oscimed SA. It received FDA 510(k) clearance on 2024-01-16 under approval number K231138. 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 Aniti-Snore Mouthguard+?
Aniti-Snore Mouthguard+ is a medical device that received FDA 510(k) clearance on 2024-01-16. It is manufactured by Oscimed SA. The 510(k) number is K231138.
When was Aniti-Snore Mouthguard+ approved by the FDA?
Aniti-Snore Mouthguard+ received FDA 510(k) clearance on 2024-01-16, under approval number K231138.
What company makes Aniti-Snore Mouthguard+?
Aniti-Snore Mouthguard+ is manufactured by Oscimed SA.
What is the FDA product code for Aniti-Snore Mouthguard+?
The FDA product code for Aniti-Snore Mouthguard+ is LRK.
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.