The following data is part of a premarket notification filed by Datrix, Inc. Dba Of Jon Barron, Inc. with the FDA for E-tac Ex-1000 Electrocardiographic Event Recorder.
| Device ID | K042022 |
| 510k Number | K042022 |
| Device Name: | E-TAC EX-1000 ELECTROCARDIOGRAPHIC EVENT RECORDER |
| Classification | Transmitters And Receivers, Electrocardiograph, Telephone |
| Applicant | DATRIX, INC. DBA OF JON BARRON, INC. 340 STATE PLACE Escondido, CA 92029 |
| Contact | Laura M Luhmann |
| Correspondent | Alfredo Quattrone CALIFORNIA DEPARTMENT OF HEALTH SERVICES 1500 CAPITOL AVENUE MAILSTOP 7602 Sacramento, CA 95814 |
| Product Code | DXH |
| CFR Regulation Number | 870.2920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2004-07-28 |
| Decision Date | 2004-08-12 |
| Summary: | summary |