The following data is part of a premarket notification filed by Ge Medical Systems Information Technologies with the FDA for Modification To Cic Pro Clinical Information Center.
| Device ID | K062976 |
| 510k Number | K062976 |
| Device Name: | MODIFICATION TO CIC PRO CLINICAL INFORMATION CENTER |
| Classification | Detector And Alarm, Arrhythmia |
| Applicant | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES 8200 WEST TOWER AVE. Milwaukee, WI 53223 |
| Contact | Lisa M Baumhardt |
| Correspondent | Lisa M Baumhardt GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES 8200 WEST TOWER AVE. Milwaukee, WI 53223 |
| Product Code | DSI |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-09-29 |
| Decision Date | 2007-03-16 |
| Summary: | summary |