The following data is part of a premarket notification filed by Neurim Pharmaceuticals, Ltd. with the FDA for Somnitor 32k Sleep Activity Monitor.
| Device ID | K965079 |
| 510k Number | K965079 |
| Device Name: | SOMNITOR 32K SLEEP ACTIVITY MONITOR |
| Classification | Device, Sleep Assessment |
| Applicant | NEURIM PHARMACEUTICALS, LTD. 12300 TWINBROOK PARKWAY, SUIT5 Rockville, MD 20852 |
| Contact | T. Whit Athey |
| Correspondent | T. Whit Athey NEURIM PHARMACEUTICALS, LTD. 12300 TWINBROOK PARKWAY, SUIT5 Rockville, MD 20852 |
| Product Code | LEL |
| CFR Regulation Number | 882.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-12-19 |
| Decision Date | 1997-07-10 |
| Summary: | summary |