UNITY NETWORK PATIENT DATA SERVER
FDA 510(k) clearance K032582 · decided 2003-09-17
Clearance details
- K-number
- K032582
- Device name
- UNITY NETWORK PATIENT DATA SERVER
- Applicant
- Ge Medical Systems Information Technologies
- Decision
- Substantially Equivalent
- Date received
- 2003-08-21
- Decision date
- 2003-09-17
- Days to decision
- 27 days
- Clearance type
- Traditional
- Product code
- MSX
- Device class
- 2
- Regulation number
- 870.2300
- 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
No recalls on record reference this clearance.
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 |