K053356 is an FDA 510(k) clearance for the MODIFICATION TO: CIC PRO CLINICAL INFORMATION CENTER CENTRAL STATION. This device is classified as a Display, Cathode-ray Tube, Medical (Class II - Special Controls, product code DXJ).
Submitted by Ge Medical Systems Information Technologies (Milwaukee, US). The FDA issued a Cleared decision on April 19, 2006, 138 days after receiving the submission on December 2, 2005.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2450.
| 510(k) Number | K053356 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 02, 2005 |
| Decision Date | April 19, 2006 |
| Days to Decision | 138 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DXJ - Display, Cathode-ray Tube, Medical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2450 |