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 Central Station.
| Device ID | K053356 |
| 510k Number | K053356 |
| Device Name: | MODIFICATION TO: CIC PRO CLINICAL INFORMATION CENTER CENTRAL STATION |
| Classification | Display, Cathode-ray Tube, Medical |
| Applicant | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES 8200 WEST TOWER AVE. Milwaukee, WI 53223 |
| Contact | Ronald N Blaski |
| Correspondent | Ronald N Blaski GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES 8200 WEST TOWER AVE. Milwaukee, WI 53223 |
| Product Code | DXJ |
| CFR Regulation Number | 870.2450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-12-02 |
| Decision Date | 2006-04-19 |
| Summary: | summary |