The following data is part of a premarket notification filed by Breas Medical Ab with the FDA for Breas Vivo Bilevel System, Model Vivo 30.
| Device ID | K060546 |
| 510k Number | K060546 |
| Device Name: | BREAS VIVO BILEVEL SYSTEM, MODEL VIVO 30 |
| Classification | Ventilator, Continuous, Non-life-supporting |
| Applicant | BREAS MEDICAL AB FORETAGSVAGEN 1 Molnlycke, Vastra Gotaland, SE Se-435 33 |
| Contact | Karl-johan Holm |
| Correspondent | Karl-johan Holm BREAS MEDICAL AB FORETAGSVAGEN 1 Molnlycke, Vastra Gotaland, SE Se-435 33 |
| Product Code | MNS |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-03-01 |
| Decision Date | 2006-05-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07321822020162 | K060546 | 000 |