The following data is part of a premarket notification filed by Medicalgorithmics S.a. with the FDA for Medical Gorithmics Unified Arrhythmia Diagnostic System.
| Device ID | K124060 |
| 510k Number | K124060 |
| Device Name: | MEDICAL GORITHMICS UNIFIED ARRHYTHMIA DIAGNOSTIC SYSTEM |
| Classification | Detector And Alarm, Arrhythmia |
| Applicant | MEDICALGORITHMICS S.A. 245 WEST 107TH ST. SUITE 11A New York, NY 10025 |
| Contact | Martin Jasinski |
| Correspondent | Martin Jasinski MEDICALGORITHMICS S.A. 245 WEST 107TH ST. SUITE 11A New York, NY 10025 |
| Product Code | DSI |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-12-31 |
| Decision Date | 2013-02-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05903021560063 | K124060 | 000 |
| 05903021560049 | K124060 | 000 |
| 05903021560032 | K124060 | 000 |
| 05903021560018 | K124060 | 000 |
| 05903021560001 | K124060 | 000 |