510(k) DEN140032
- Device
- Cereve Sleep System
- Applicant
- Cereve, Inc.
- 510(k) number
- DEN140032
- Product code
- PLU
- Decision
- Unknown (DENG)
- Decision date
- 2016-05-13
- Date received
- 2014-10-20
- Regulation
- 882.5700
- Classification name
- Thermal System For Insomnia
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Eric Nofzinger
- Address
- 333 Allegheny Ave., 2nd Floor N. Oakmont PA US 15139 15139
Source Documents#
510(k) summary PDF not indicated by FDA