K172862 is an FDA 510(k) clearance for the Portable ECG Monitor (ECG3). This device is classified as a Recorder, Magnetic Tape, Medical (Class II - Special Controls, product code DSH).
Submitted by Andon Health Co, Ltd. (Tianjin, CN). The FDA issued a Cleared decision on July 24, 2018, 307 days after receiving the submission on September 20, 2017.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2800.
| 510(k) Number | K172862 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 20, 2017 |
| Decision Date | July 24, 2018 |
| Days to Decision | 307 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Statement |
| Product Code | DSH — Recorder, Magnetic Tape, Medical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2800 |