Somnos Anti-Snoring Mouth Guard
K-Number: K201484 · 2020-11-23
ApplicantKoncept Innovators, LLC
Decision Date2020-11-23
Product CodeLRK
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Somnos Anti-Snoring Mouth Guard is a medical device manufactured by Koncept Innovators, LLC. It received FDA 510(k) clearance on 2020-11-23 under approval number K201484. 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 Somnos Anti-Snoring Mouth Guard?
Somnos Anti-Snoring Mouth Guard is a medical device that received FDA 510(k) clearance on 2020-11-23. It is manufactured by Koncept Innovators, LLC. The 510(k) number is K201484.
When was Somnos Anti-Snoring Mouth Guard approved by the FDA?
Somnos Anti-Snoring Mouth Guard received FDA 510(k) clearance on 2020-11-23, under approval number K201484.
What company makes Somnos Anti-Snoring Mouth Guard?
Somnos Anti-Snoring Mouth Guard is manufactured by Koncept Innovators, LLC.
What is the FDA product code for Somnos Anti-Snoring Mouth Guard?
The FDA product code for Somnos Anti-Snoring Mouth Guard is LRK.
Related Clinical Trials
Other Devices by Koncept Innovators, LLC
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.