K173461 is an FDA 510(k) clearance for the ECG recorder and Arrhythmia Detector. This device is classified as a Recorder, Magnetic Tape, Medical (Class II - Special Controls, product code DSH).
Submitted by Smart Solutions Technologies SL (Madrid, ES). The FDA issued a Cleared decision on August 3, 2018, 269 days after receiving the submission on November 7, 2017.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2800.
| 510(k) Number | K173461 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 07, 2017 |
| Decision Date | August 03, 2018 |
| Days to Decision | 269 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DSH - Recorder, Magnetic Tape, Medical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2800 |