The following data is part of a premarket notification filed by Sleepnet Corporation with the FDA for Mojo 2 Full Face Non-vented Mask, Mojo 2 Aav Non-vented Full-face Mask, Veraseal 3 Full Face Non-vented Mask, Veraseal 3 Full Face Aav Non-vented.
| Device ID | K190533 |
| 510k Number | K190533 |
| Device Name: | Mojo 2 Full Face Non-Vented Mask, Mojo 2 AAV Non-Vented Full-Face Mask, Veraseal 3 Full Face Non-Vented Mask, Veraseal 3 Full Face AAV Non-Vented |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | Sleepnet Corporation 5 Merrill Industrial Drive Hampton, NH 03842 |
| Contact | Jennifer Kennedy |
| Correspondent | Paul Dryden Sleepnet Corporation % ProMedic, LLC 131 Bay Point Dr NE St. Petersburg, FL 33704 |
| Product Code | CBK |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-03-04 |
| Decision Date | 2019-07-26 |
| Summary: | summary |