The following data is part of a premarket notification filed by Medicalgorithmics S.a. with the FDA for Medicalgorithmics Unified Cardiac Rehabilitation System.
| Device ID | K173969 |
| 510k Number | K173969 |
| Device Name: | Medicalgorithmics Unified Cardiac Rehabilitation System |
| Classification | Detector And Alarm, Arrhythmia |
| Applicant | Medicalgorithmics S.A. Aleje Jerozolimskie 81 Warsaw, PL 02-001 |
| Contact | Marek Dziubinski |
| Correspondent | Przemyslaw Tadla Medicalgorithmics US Holding Corporation 2711 Centerville Rd Ste 400 Wilmington, DE 19808 |
| Product Code | DSI |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-12-29 |
| Decision Date | 2018-07-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05903021560056 | K173969 | 000 |