The following data is part of a premarket notification filed by Breas Medical Ab with the FDA for Breas Vivo 40 System.
| Device ID | K053607 |
| 510k Number | K053607 |
| Device Name: | BREAS VIVO 40 SYSTEM |
| Classification | Ventilator, Continuous, Minimal Ventilatory Support, Facility Use |
| Applicant | BREAS MEDICAL AB FORETAGSVAGEN 1 Molnlycke, SE Se-435 33 |
| Contact | Karl-johan Holm |
| Correspondent | Karl-johan Holm BREAS MEDICAL AB FORETAGSVAGEN 1 Molnlycke, SE 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 | 2005-12-27 |
| Decision Date | 2006-03-16 |
| Summary: | summary |