Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K160481
Vivo 60 · Breas Medical AB · decided 2016-11-09 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| Vivo 45 LS, Vivo 65 | 006361 | Breas Medical AB | CBK NOU | 07321820063611 |
| Vivo 65 | 005525 | Breas Medical AB | CBK NOU | 07321820055258 |
| Vivo 45 LS, Vivo 65 | 006349 | Breas Medical AB | CBK NOU | 07321820063499 |
| Vivo 45 LS, Vivo 65 | 006364 | Breas Medical AB | CBK NOU | 07321820063642 |
| Vivo 65 | 006342 | Breas Medical AB | CBK NOU | 07321820063420 |
| Vivo 45 LS, Vivo 65 | 006365 | Breas Medical AB | CBK NOU | 07321820063659 |
| Vivo 65 | 005521 | Breas Medical AB | CBK NOU | 07321820055210 |
| Vivo 45 LS, Vivo 65 | 006348 | Breas Medical AB | CBK NOU | 07321820063482 |
| Vivo 45 LS, Vivo 65 | 006360 | Breas Medical AB | CBK NOU | 07321820063604 |
| Vivo 45 LS, Vivo 65 | 006362 | Breas Medical AB | CBK NOU | 07321820063628 |
| Vivo 65 | 006435 | Breas Medical AB | CBK NOU | 07321820064359 |
| Vivo 45 LS, Vivo 65 | 006363 | Breas Medical AB | CBK NOU | 07321820063635 |
| Vivo 45 LS, Vivo 65 | 006369 | Breas Medical AB | CBK NOU | 07321820063697 |
| Vivo 65 | 005432 | Breas Medical AB | CBK NOU | 07321820054329 |
| Vivo 65 | US | Breas Medical AB | NOU | 07321822240003 |
| Vivo 45 LS, Vivo 65 | 006359 | Breas Medical AB | CBK NOU | 07321820063598 |
| Vivo 65 | 005523 | Breas Medical AB | CBK NOU | 07321820055234 |