ApnoDent Appliance
K-Number: K181123 · 2018-11-21
ApplicantApnomed, Inc.
Decision Date2018-11-21
Product CodeLRK
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
ApnoDent Appliance is a medical device manufactured by Apnomed, Inc.. It received FDA 510(k) clearance on 2018-11-21 under approval number K181123. 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 ApnoDent Appliance?
ApnoDent Appliance is a medical device that received FDA 510(k) clearance on 2018-11-21. It is manufactured by Apnomed, Inc.. The 510(k) number is K181123.
When was ApnoDent Appliance approved by the FDA?
ApnoDent Appliance received FDA 510(k) clearance on 2018-11-21, under approval number K181123.
What company makes ApnoDent Appliance?
ApnoDent Appliance is manufactured by Apnomed, Inc..
What is the FDA product code for ApnoDent Appliance?
The FDA product code for ApnoDent Appliance 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.