SLEEPAPP
K-Number: K182202 · 2019-01-11
ApplicantComfort Acrylics, Inc.
Decision Date2019-01-11
Product CodeLRK
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
SLEEPAPP is a medical device manufactured by Comfort Acrylics, Inc.. It received FDA 510(k) clearance on 2019-01-11 under approval number K182202. 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 SLEEPAPP?
SLEEPAPP is a medical device that received FDA 510(k) clearance on 2019-01-11. It is manufactured by Comfort Acrylics, Inc.. The 510(k) number is K182202.
When was SLEEPAPP approved by the FDA?
SLEEPAPP received FDA 510(k) clearance on 2019-01-11, under approval number K182202.
What company makes SLEEPAPP?
SLEEPAPP is manufactured by Comfort Acrylics, Inc..
What is the FDA product code for SLEEPAPP?
The FDA product code for SLEEPAPP 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.