The following data is part of a premarket notification filed by Datrix with the FDA for Datrix Cardio Wifi Electrocardiograph.
| Device ID | K053083 |
| 510k Number | K053083 |
| Device Name: | DATRIX CARDIO WIFI ELECTROCARDIOGRAPH |
| Classification | Electrocardiograph |
| Applicant | DATRIX 340 STATE PLACE Escondido, CA 92029 |
| Contact | Linda Gluckman |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2005-11-02 |
| Decision Date | 2005-11-30 |
| Summary: | summary |