| K-number | K053083 |
| Device name | DATRIX CARDIO WIFI ELECTROCARDIOGRAPH |
| Applicant | Datrix |
| Product code | DPS |
| Device class | Class II |
| Decision date | Nov 30, 2005 |
| Decision | Substantially Equivalent |
| Regulation | 870.2340 |
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