The following data is part of a premarket notification filed by Sleepnet Corporation with the FDA for Sleepnet Mojo Full Face Mask -small, Model No. 53835, Medium ,model No.53836,large,model No. 53837.
| Device ID | K060273 |
| 510k Number | K060273 |
| Device Name: | SLEEPNET MOJO FULL FACE MASK -SMALL, MODEL NO. 53835, MEDIUM ,MODEL NO.53836,LARGE,MODEL NO. 53837 |
| Classification | Ventilator, Non-continuous (respirator) |
| 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 | BZD |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-02-02 |
| Decision Date | 2006-05-02 |
| Summary: | summary |