The following data is part of a premarket notification filed by Breas Medical Ab with the FDA for Vivo 45 Ls.
| Device ID | K193586 |
| 510k Number | K193586 |
| Device Name: | Vivo 45 LS |
| Classification | Continuous, Ventilator, Home Use |
| Applicant | Breas Medical AB Foretagsvagen 1 Molnlyeke, SE Se-453 33 |
| Contact | Ari Sobel |
| Correspondent | Maureen O'connell O'Connell Regulatory Consultants, Inc. 44 Oak Street Stoneham, MA 02180 |
| Product Code | NOU |
| Subsequent Product Code | BTT |
| 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 | 2019-12-23 |
| Decision Date | 2021-01-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07321822300004 | K193586 | 000 |
| 07321820067107 | K193586 | 000 |
| 07321820067091 | K193586 | 000 |
| 07321820066490 | K193586 | 000 |
| 07321820063963 | K193586 | 000 |
| 07321820062652 | K193586 | 000 |
| 07321820061808 | K193586 | 000 |
| 07321820061792 | K193586 | 000 |
| 07321820061723 | K193586 | 000 |
| 07321820060672 | K193586 | 000 |
| 07321820060146 | K193586 | 000 |
| 07321820067114 | K193586 | 000 |
| 07321820070640 | K193586 | 000 |
| 07321820084364 | K193586 | 000 |
| 07321820083923 | K193586 | 000 |
| 07321820077335 | K193586 | 000 |
| 07321820077328 | K193586 | 000 |
| 07321820076543 | K193586 | 000 |
| 07321820075553 | K193586 | 000 |
| 07321820065561 | K193586 | 000 |
| 07321820064564 | K193586 | 000 |
| 07321820064571 | K193586 | 000 |
| 07321820070671 | K193586 | 000 |
| 07321820035229 | K193586 | 000 |