510(k) K182202
K182202 is an FDA 510(k) premarket notification submitted by Comfort Acrylics, Inc. for the device "SLEEPAPP". The FDA issued a decision of Substantially Equivalent on Jan 11, 2019. The device falls under product code LRK (Device, Anti-Snoring), a Class II device regulated under 21 CFR 872.5570. Comfort Acrylics, Inc. has 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 11, 2019
- Date Received
- Aug 14, 2018
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, Anti-Snoring
- Device Class
- Class II
- Regulation Number
- 872.5570
- Review Panel
- DE
- Submission Type
- 510(k)