VIVO 50
FDA 510(k) clearance K123144 · decided 2013-06-18
Clearance details
- K-number
- K123144
- Device name
- VIVO 50
- Applicant
- Ge Healthcare, Breas Medical AB
- Decision
- Substantially Equivalent
- Date received
- 2012-10-05
- Decision date
- 2013-06-18
- Days to decision
- 256 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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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Breas Vivo 50 Home Care Ventilator Product Usage: Respiratory Care recall (Z-2094-2015) | Breas Medical AB | 2015-07-16 |