The following data is part of a premarket notification filed by Ge Medical Systems Information Technologies, Inc. with the FDA for Carescape Central Station (formally Known As Cic Pro).
| Device ID | K133882 |
| 510k Number | K133882 |
| Device Name: | CARESCAPE CENTRAL STATION (FORMALLY KNOWN AS CIC PRO) |
| Classification | Display, Cathode-ray Tube, Medical |
| Applicant | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. 8200 WEST TOWER AVE. Milwaukee, WI 53223 |
| Contact | Robert Casarsa |
| Correspondent | Robert Casarsa GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. 8200 WEST TOWER AVE. Milwaukee, WI 53223 |
| Product Code | DXJ |
| Subsequent Product Code | BSE |
| Subsequent Product Code | BZQ |
| Subsequent Product Code | CBQ |
| Subsequent Product Code | CBR |
| Subsequent Product Code | CBS |
| Subsequent Product Code | CCI |
| Subsequent Product Code | CCK |
| Subsequent Product Code | CCL |
| Subsequent Product Code | DOA |
| Subsequent Product Code | DPT |
| Subsequent Product Code | DSB |
| Subsequent Product Code | DSK |
| Subsequent Product Code | DXN |
| Subsequent Product Code | FLL |
| Subsequent Product Code | GWQ |
| Subsequent Product Code | JEG |
| Subsequent Product Code | NHO |
| Subsequent Product Code | NHP |
| Subsequent Product Code | NHQ |
| Subsequent Product Code | &nb |
| CFR Regulation Number | 870.2450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-12-20 |
| Decision Date | 2014-04-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682109833 | K133882 | 000 |
| 00840682109826 | K133882 | 000 |