The following data is part of a premarket notification filed by Sleepnet Corporation with the FDA for Iq Nasal Mask, Model P/n 50160.
| Device ID | K993269 |
| 510k Number | K993269 |
| Device Name: | IQ NASAL MASK, MODEL P/N 50160 |
| Classification | Ventilator, Non-continuous (respirator) |
| Applicant | SLEEPNET CORPORATION 1050 PERIMETER RD., LOCKHEED AIR CENTER Manchester, NH 03103 |
| Contact | Paul R Chiesa |
| Correspondent | Paul R Chiesa SLEEPNET CORPORATION 1050 PERIMETER RD., LOCKHEED AIR CENTER Manchester, NH 03103 |
| Product Code | BZD |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-09-30 |
| Decision Date | 1999-10-27 |