510(k) K965079
K965079 is an FDA 510(k) premarket notification submitted by Neurim Pharmaceuticals, Ltd. for the device "SOMNITOR 32K SLEEP ACTIVITY MONITOR". The FDA issued a decision of Substantially Equivalent on July 10, 1997. The device falls under product code LEL (Device, Sleep Assessment), a Class II device regulated under 21 CFR 882.5050.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 10, 1997
- Date Received
- December 19, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, Sleep Assessment
- Device Class
- Class II
- Regulation Number
- 882.5050
- Review Panel
- NE
- Submission Type