510(k) K153291
K153291 is an FDA 510(k) premarket notification submitted by Sicat GmbH & Co. KG for the device "SICAT OPTISLEEP". The FDA issued a decision of Substantially Equivalent on March 31, 2016. The device falls under product code LRK (Device, Anti-Snoring), a Class II device regulated under 21 CFR 872.5570. Sicat GmbH & Co. KG has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 31, 2016
- Date Received
- November 13, 2015
- 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