The following data is part of a premarket notification filed by Medicalgorithmics S.a. with the FDA for Medicalgorithmics Unified Arrhythmia Diagnosic System.
| Device ID | K152550 |
| 510k Number | K152550 |
| Device Name: | MEDICALGORITHMICS UNIFIED ARRHYTHMIA DIAGNOSIC SYSTEM |
| Classification | Detector And Alarm, Arrhythmia |
| Applicant | MEDICALGORITHMICS S.A. AI. JEROZOLIMSKIE 81 Warsaw, PL 02-001 |
| Contact | Marek J. Dziubinski |
| Correspondent | Martin Jasinski MEDICALGORITHMICS LLC. 245 WEST 107TH STREET SUITE 11 A New York, NY 10025 |
| Product Code | DSI |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-08 |
| Decision Date | 2015-10-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05903021560025 | K152550 | 000 |