MONITOR B40
FDA 510(k) clearance K133576 · decided 2014-02-21
Clearance details
- K-number
- K133576
- Device name
- MONITOR B40
- Applicant
- Ge Medical Systems China Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2013-11-20
- Decision date
- 2014-02-21
- Days to decision
- 93 days
- Clearance type
- Special
- 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
+ Add to Predicate Builder ◉ Watch Ge Medical Systems China Co.
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Airway Gas Option N-CAiO recall (Z-0760-2020) | GE Healthcare, LLC | 2020-01-10 |
| CARESCAPE Respiratory Modules E-sCO, E-sCOV, E-sCAiO, E-sCAiOV, E-sCAiOE, E-sCAiOVE; the A recall (Z-2617-2014) | GE Healthcare, LLC | 2014-09-09 |