The following data is part of a premarket notification filed by Sleepnet Corporation with the FDA for Hard Shell Vented Nasal Mask.
| Device ID | K121321 |
| 510k Number | K121321 |
| Device Name: | HARD SHELL VENTED NASAL MASK |
| Classification | Ventilator, Non-continuous (respirator) |
| Applicant | SLEEPNET CORPORATION 24301 WOODSAGE DRIVE Bonita Springs, FL 34134 -2958 |
| Contact | Paul Dryden |
| Correspondent | Paul Dryden SLEEPNET CORPORATION 24301 WOODSAGE DRIVE Bonita Springs, FL 34134 -2958 |
| Product Code | BZD |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-05-02 |
| Decision Date | 2012-11-30 |
| Summary: | summary |