Vivo 45 LS
FDA 510(k) clearance K233452 · decided 2025-01-13
Clearance details
- K-number
- K233452
- Device name
- Vivo 45 LS
- Applicant
- Breas Medical AB
- Decision
- Substantially Equivalent
- Date received
- 2023-10-20
- Decision date
- 2025-01-13
- Days to decision
- 451 days
- Clearance type
- Traditional
- Product code
- NOU
- Device class
- 2
- Regulation number
- 868.5895
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Molnlycke, SE
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Vivo 45 LS (K193586) | Breas Medical AB | 2021-01-27 |
| Vivo 60 (K160481) | Breas Medical AB | 2016-11-09 |
| VIVO 50 (K123144) | Ge Healthcare, Breas Medical AB | 2013-06-18 |
| PLV CONTINUUM VENTILATOR, MODEL P2000 (K034032) | Respironics California, Inc. | 2004-03-16 |
| PLV CONTINUUM VENTILATOR, MODEL P1000 (K022750) | Respironics California, Inc. | 2003-11-20 |
| IVENT 201 PORTABLE VENTILATOR (K021981) | Versamed , Ltd. | 2003-08-13 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| with Notch 22M/15F sold as part of Breas Medical MPV circuit 2 pc Kits: 006093, 006653, an recall (Z-0405-2024) | Breas Medical, Inc. | 2023-11-27 |