The following data is part of a premarket notification filed by Datrix with the FDA for Digital Ambulatory Ecg (holter) Recorder.
| Device ID | K031074 |
| 510k Number | K031074 |
| Device Name: | DIGITAL AMBULATORY ECG (HOLTER) RECORDER |
| Classification | Electrocardiograph, Ambulatory (without Analysis) |
| Applicant | DATRIX 340 STATE PLACE Escondido, CA 92029 |
| Contact | Lauren M Luhmann |
| Correspondent | Lauren M Luhmann DATRIX 340 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 | 2003-04-04 |
| Decision Date | 2003-10-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00851074007316 | K031074 | 000 |
| 00851074007361 | K031074 | 000 |