K112921 is an FDA 510(k) clearance for the MEDICALGORITHMICS UNIFIED ARRHYTHMIA DIAGNOSTIC SYSTEM. This device is classified as a Detector And Alarm, Arrhythmia (Class II - Special Controls, product code DSI).
Submitted by Medicalgorithmics S.A. (New York, US). The FDA issued a Cleared decision on May 16, 2012, 226 days after receiving the submission on October 3, 2011.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1025.
| 510(k) Number | K112921 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 03, 2011 |
| Decision Date | May 16, 2012 |
| Days to Decision | 226 days |
| Submission Type | Abbreviated |
| 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 |