The following data is part of a premarket notification filed by Sleep Solutions, Inc. with the FDA for Silent Night Ii.
| Device ID | K981034 |
| 510k Number | K981034 |
| Device Name: | SILENT NIGHT II |
| Classification | Ventilatory Effort Recorder |
| Applicant | SLEEP SOLUTIONS, INC. 9223 ILONA LN. Houston, TX 77025 |
| Contact | Lisa S Jones |
| Correspondent | Lisa S Jones SLEEP SOLUTIONS, INC. 9223 ILONA LN. Houston, TX 77025 |
| Product Code | MNR |
| CFR Regulation Number | 868.2375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-03-19 |
| Decision Date | 1998-10-30 |
| Summary: | summary |