CARESCAPE MONITOR B650
FDA 510(k) clearance K131223 · decided 2013-08-28
Clearance details
- K-number
- K131223
- Device name
- CARESCAPE MONITOR B650
- Applicant
- GE Healthcare Finland Oy
- Decision
- Substantially Equivalent
- Date received
- 2013-04-30
- Decision date
- 2013-08-28
- Days to decision
- 120 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 |
|---|---|---|
| GE Healthcare, CARESCAPE Monitor B850, B650 and B450 (Bx50). recall (Z-1606-2015) | GE Healthcare | 2015-05-12 |
| GE Healthcare, CARESCAPE Monitor B850, B650 or B450. Patient Monitor. recall (Z-2085-2014) | GE Healthcare, LLC | 2014-07-21 |
| GE Healthcare CARESCAPE Monitor B650 and CARESCAPE Monitor B850. K102239 CARESCAPE Monitor recall (Z-1175-2014) | GE Healthcare, LLC | 2014-03-11 |