MODIFICATION TO CIC PRO CLINICAL INFORMATION CENTER
FDA 510(k) clearance K062976 · decided 2007-03-16
Clearance details
- K-number
- K062976
- Device name
- MODIFICATION TO CIC PRO CLINICAL INFORMATION CENTER
- Applicant
- Ge Medical Systems Information Technologies
- Decision
- Substantially Equivalent
- Date received
- 2006-09-29
- Decision date
- 2007-03-16
- Days to decision
- 168 days
- Clearance type
- Special
- Product code
- DSI
- 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 CIC Pro Clinical Information Center Central Station (CIC Pro version 5.1, MP recall (Z-1600-2009) | GE Medical Systems Information Tecnology | 2009-09-04 |
| GE Healthcare CIC Pro" Software Versions 5.0.3, 5.0.6 ,5.0.7, 5.0.8 and 4.1. The CIC Pro" recall (Z-1232-2009) | GE Medical Systems Information Tecnology | 2009-05-04 |
| GE Medical Systems Information Technologies Clinical Information Center (CIC) Pro v5.0.3 & recall (Z-0519-2008) | General Electric Medical Systems Information Technology | 2008-01-17 |
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 |