The following data is part of a premarket notification filed by Breas Medical Ab with the FDA for Breas Vivo Bilevel System, Model Vivo 40.
| Device ID | K071702 |
| 510k Number | K071702 |
| Device Name: | BREAS VIVO BILEVEL SYSTEM, MODEL VIVO 40 |
| Classification | Ventilator, Continuous, Minimal Ventilatory Support, Facility Use |
| Applicant | BREAS MEDICAL AB FORETAGSVAGEN 1 Molnlycke, SE 435 33 |
| Contact | Ibb Jessen |
| Correspondent | Ibb Jessen BREAS MEDICAL AB FORETAGSVAGEN 1 Molnlycke, SE 435 33 |
| Product Code | MNT |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-06-21 |
| Decision Date | 2008-02-15 |
| Summary: | summary |