CARESCAPE B450, E-musb
FDA 510(k) clearance K213363 · decided 2022-04-13
Clearance details
- K-number
- K213363
- Device name
- CARESCAPE B450, E-musb
- Applicant
- GE Healthcare Finland Oy
- Decision
- Substantially Equivalent
- Date received
- 2021-10-12
- Decision date
- 2022-04-13
- Days to decision
- 183 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 B450, Model no. 5805686 - shipped with potentially affected batteries or affecte recall (Z-0453-2026) | GE Healthcare Finland Oy | 2025-11-07 |