AWARE TRANSPORT MONITOR SYSTEM (INCLUDES AWARE POD AND AWARE TRANSPORT MONITOR)
FDA 510(k) clearance K042642 · decided 2004-11-03
Clearance details
- K-number
- K042642
- Device name
- AWARE TRANSPORT MONITOR SYSTEM (INCLUDES AWARE POD AND AWARE TRANSPORT MONITOR)
- Applicant
- Ge Medical Systems Information Technologies
- Decision
- Substantially Equivalent
- Date received
- 2004-09-27
- Decision date
- 2004-11-03
- Days to decision
- 37 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 |
|---|---|---|
| GE Healthcare, Invasive Blood Pressure Care Cables. Product ID Number: 2016995-001, 201699 recall (Z-2015-2012) | GE Healthcare, LLC | 2012-07-16 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| COROMETRICS MODEL 120 F-SERIES MATERNAL/FETAL MONITOR WITH INTERGRATED FETAL OXYGEN SATURATION MONITORING (P000016/S002) | Ge Medical Systems Information Technologies | 2003-10-15 |
| COROMETRICS MODEL 120 SERIES MATERNAL/FETAL MONITOR W/INTEGRATED FETAL PULSE OXIMETRY (P000016/S001) | Ge Medical Systems Information Technologies | 2001-11-09 |
| COROMETRICS 120F SERIES MATERNAL/FETAL MONITOR (P000016) | Ge Medical Systems Information Technologies | 2001-02-09 |
| MODEL 515 NEONATAL MONIOTR (P840037/S001) | Ge Medical Systems Information Technologies | 1986-11-19 |