MONITOR B40
FDA 510(k) clearance K130584 · decided 2013-06-26
Clearance details
- K-number
- K130584
- Device name
- MONITOR B40
- Applicant
- Ge Medical Systems China Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2013-03-05
- Decision date
- 2013-06-26
- Days to decision
- 113 days
- Clearance type
- Traditional
- Product code
- MHX
- Device class
- 2
- Regulation number
- 870.1025
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Milwaukee, WI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| HGE Healthcare Patient Monitor B30, Procare Monitor B20, Procare Monitor B40, and Monitor recall (Z-0489-2014) | GE Healthcare, LLC | 2013-12-12 |