The following data is part of a premarket notification filed by Medicalgorithmics S.a. with the FDA for Unified Arrhythmia Diagnostic System Pocketecg Iv.
| Device ID | K193104 |
| 510k Number | K193104 |
| Device Name: | Unified Arrhythmia Diagnostic System PocketECG IV |
| 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 Corporation Service Company 251 Little Falls Drive Wilmington, DE 19808 |
| Product Code | DSI |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-11-08 |
| Decision Date | 2020-04-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05903021560117 | K193104 | 000 |
| 05903021560100 | K193104 | 000 |
| 05903021560094 | K193104 | 000 |
| 05903021560087 | K193104 | 000 |
| 05903021560070 | K193104 | 000 |