The following data is part of a premarket notification filed by Sleepnet Corporation with the FDA for Dpap Stealth Sleepnet Model Number 84000.
| Device ID | K962713 |
| 510k Number | K962713 |
| Device Name: | DPAP STEALTH SLEEPNET MODEL NUMBER 84000 |
| Classification | Ventilator, Non-continuous (respirator) |
| Applicant | SLEEPNET CORPORATION 1050 PERIMETER RD., LOCKHEED AIR CENTER Manchester, NH 03103 |
| Contact | Ronald L Cotner |
| Correspondent | Ronald L Cotner SLEEPNET CORPORATION 1050 PERIMETER RD., LOCKHEED AIR CENTER Manchester, NH 03103 |
| Product Code | BZD |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-07-12 |
| Decision Date | 1996-10-23 |