Andon Health Co, Ltd. · Class II · Cleared Jul 24, 2018
| K-number | K172862 |
| Device name | Portable ECG Monitor (ECG3) |
| Applicant | Andon Health Co, Ltd. |
| Product code | DSH |
| Device class | Class II |
| Decision date | Jul 24, 2018 |
| Decision | Substantially Equivalent |
| Regulation | 870.2800 |
AI extraction for this record is queued and will appear within 24 hours. View full FDA record →
View the full FDA submission: accessdata.fda.gov