The following data is part of a premarket notification filed by Breas Medical Ab with the FDA for Vivo 60.
| Device ID | K160481 |
| 510k Number | K160481 |
| Device Name: | Vivo 60 |
| Classification | Continuous, Ventilator, Home Use |
| Applicant | BREAS MEDICAL AB FORETAGSVAGEN 1 Molnlycke Vastra Gotalands Lan, SE 435 33 |
| Contact | Albert Cefalo |
| Correspondent | Maureen O'connell O'CONNELL REGULATORY CONSULTANTS, INC. 5 TIMBER LANE North Reading, MA 01864 |
| Product Code | NOU |
| Subsequent Product Code | CBK |
| Subsequent Product Code | CCK |
| Subsequent Product Code | DQA |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-02-22 |
| Decision Date | 2016-11-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07321822245169 | K160481 | 000 |
| 07321820055210 | K160481 | 000 |
| 07321820057900 | K160481 | 000 |
| 07321820057917 | K160481 | 000 |
| 07321820063420 | K160481 | 000 |
| 07321820063482 | K160481 | 000 |
| 07321820063499 | K160481 | 000 |
| 07321820063598 | K160481 | 000 |
| 07321820063604 | K160481 | 000 |
| 07321820063611 | K160481 | 000 |
| 07321820063628 | K160481 | 000 |
| 07321820063635 | K160481 | 000 |
| 07321820063642 | K160481 | 000 |
| 07321820063659 | K160481 | 000 |
| 07321820063697 | K160481 | 000 |
| 07321820061259 | K160481 | 000 |
| 07321820054329 | K160481 | 000 |