The following data is part of a premarket notification filed by Sleepnet Corporation with the FDA for The Ims Dpap Mask, Ims Model Number 82000.
| Device ID | K953697 |
| 510k Number | K953697 |
| Device Name: | THE IMS DPAP MASK, IMS MODEL NUMBER 82000 |
| Classification | Ventilator, Non-continuous (respirator) |
| Applicant | SLEEPNET CORPORATION 1050 PERIMETER RD. LOCKHEED AIR CENTER Manchester, NH 03103 |
| Contact | Rita M Wadleigh |
| Correspondent | Rita M Wadleigh 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 | 1995-08-08 |
| Decision Date | 1996-06-13 |