The following data is part of a premarket notification filed by Datrix with the FDA for Digital Ecg Holter Recorder, Model Dr512.
| Device ID | K982975 |
| 510k Number | K982975 |
| Device Name: | DIGITAL ECG HOLTER RECORDER, MODEL DR512 |
| Classification | Electrocardiograph, Ambulatory (without Analysis) |
| Applicant | DATRIX 316 STATE PLACE Escondido, CA 92029 |
| Contact | Jon Barron |
| Correspondent | Jon Barron DATRIX 316 STATE PLACE Escondido, CA 92029 |
| Product Code | MWJ |
| CFR Regulation Number | 870.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-08-26 |
| Decision Date | 1998-11-10 |
| Summary: | summary |