The following data is part of a premarket notification filed by Sleepnet Corporation with the FDA for Sleepnet Mojo -nv Full Face Mask, Non-vented.
| Device ID | K063806 |
| 510k Number | K063806 |
| Device Name: | SLEEPNET MOJO -NV FULL FACE MASK, NON-VENTED |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | SLEEPNET CORPORATION 1050 PERIMETER RD. MANCHESTER AIR CENTER Manchester, NH 03103 |
| Contact | Paul Chiesa |
| Correspondent | Paul Chiesa SLEEPNET CORPORATION 1050 PERIMETER RD. MANCHESTER AIR CENTER Manchester, NH 03103 |
| Product Code | CBK |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-12-22 |
| Decision Date | 2007-05-17 |
| Summary: | summary |