CARESCAPE B650
FDA 510(k) clearance K191149 · decided 2020-01-21
Clearance details
- K-number
- K191149
- Device name
- CARESCAPE B650
- Applicant
- GE Healthcare Finland Oy
- Decision
- Substantially Equivalent
- Date received
- 2019-04-30
- Decision date
- 2020-01-21
- Days to decision
- 266 days
- Clearance type
- Traditional
- Product code
- MHX
- Device class
- 2
- Regulation number
- 870.1025
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Helsinki, FI
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| CARESCAPE B650: Model Numbers: a) MBB313, Model Numbers: 1) 2095801-001, 2) 2095801-001-01 recall (Z-2171-2024) | GE Healthcare Finland Oy | 2024-06-21 |
| CARESCAPE B850 Model Numbers: a) MBC303, Model Numbers: 1) 2078633-001, 2) 2078633-010, 3) recall (Z-2172-2024) | GE Healthcare Finland Oy | 2024-06-21 |