The following data is part of a premarket notification filed by Sleep Solutions, Inc. with the FDA for Silent Night V.
| Device ID | K000253 |
| 510k Number | K000253 |
| Device Name: | SILENT NIGHT V |
| Classification | Ventilatory Effort Recorder |
| Applicant | SLEEP SOLUTIONS, INC. 928 LINDEN AVE. Burlingame, CA 94010 |
| Contact | Carole M Sykes |
| Correspondent | Carole M Sykes SLEEP SOLUTIONS, INC. 928 LINDEN AVE. Burlingame, CA 94010 |
| Product Code | MNR |
| CFR Regulation Number | 868.2375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-01-27 |
| Decision Date | 2000-11-16 |
| Summary: | summary |