The following data is part of a premarket notification filed by Sleepnet Corporation with the FDA for Mojo 2 Full Face Vented Mask, Veraseal 3 Full Face Vented Mask, V3 Full Face Vented Mask.
| Device ID | K190254 |
| 510k Number | K190254 |
| Device Name: | Mojo 2 Full Face Vented Mask, Veraseal 3 Full Face Vented Mask, V3 Full Face Vented Mask |
| Classification | Ventilator, Non-continuous (respirator) |
| 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 | BZD |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-02-07 |
| Decision Date | 2019-07-05 |