K193104 is an FDA 510(k) clearance for the Unified Arrhythmia Diagnostic System PocketECG IV. This device is classified as a Detector And Alarm, Arrhythmia (Class II - Special Controls, product code DSI).
Submitted by Medicalgorithmics S.A. (Warsaw, PL). The FDA issued a Cleared decision on April 9, 2020, 153 days after receiving the submission on November 8, 2019.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1025.
| 510(k) Number | K193104 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 08, 2019 |
| Decision Date | April 09, 2020 |
| Days to Decision | 153 days |
| Submission Type | Special |
| 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 |