K032370 is an FDA 510(k) clearance for the CIC PRO CLINICAL INFORMATION CENTER CENTRAL STATION. This device is classified as a Detector And Alarm, Arrhythmia (Class II - Special Controls, product code DSI).
Submitted by Ge Medical Systems Information Technologies (Milwaukee, US). The FDA issued a Cleared decision on August 13, 2003, 12 days after receiving the submission on August 1, 2003.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1025.
| 510(k) Number | K032370 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 01, 2003 |
| Decision Date | August 13, 2003 |
| Days to Decision | 12 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DSI - Detector And Alarm, Arrhythmia |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1025 |