510(k) DEN140032
DEN140032 is an FDA 510(k) premarket notification submitted by Cereve, Inc. for the device "Cereve Sleep System". The FDA issued a decision of De Novo Granted on May 13, 2016. The device falls under product code PLU (Thermal System For Insomnia), a Class II device regulated under 21 CFR 882.5700.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- May 13, 2016
- Date Received
- October 20, 2014
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Thermal System For Insomnia
- Device Class
- Class II
- Regulation Number
- 882.5700
- Review Panel
- NE
- Submission Type
A thermal system for insomnia is a prescription device for use in patients with insomnia that is used to apply a specified temperature to the skin surface.