The following data is part of a premarket notification filed by Sleepnet Corporation with the FDA for Sleepnet Humidifier,(84200 Packaged).
| Device ID | K963025 |
| 510k Number | K963025 |
| Device Name: | SLEEPNET HUMIDIFIER,(84200 PACKAGED) |
| Classification | Humidifier, Respiratory Gas, (direct Patient Interface) |
| Applicant | SLEEPNET CORPORATION 1050 PERIMETER RD., LOCKHEED AIR CENTER Manchester, NH 03103 |
| Contact | Thomas E Asacker |
| Correspondent | Thomas E Asacker SLEEPNET CORPORATION 1050 PERIMETER RD., LOCKHEED AIR CENTER Manchester, NH 03103 |
| Product Code | BTT |
| CFR Regulation Number | 868.5450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-08-05 |
| Decision Date | 1996-11-01 |