The following data is part of a premarket notification filed by Telescan Medical Systems with the FDA for Cardiac Event Recorder (instant Memory 2000).
| Device ID | K942586 |
| 510k Number | K942586 |
| Device Name: | CARDIAC EVENT RECORDER (INSTANT MEMORY 2000) |
| Classification | Transmitters And Receivers, Electrocardiograph, Telephone |
| Applicant | TELESCAN MEDICAL SYSTEMS 26424 TABLE MEADOW RD. Auburn, CA 95062 |
| Contact | Stanley Wegner |
| Correspondent | Stanley Wegner TELESCAN MEDICAL SYSTEMS 26424 TABLE MEADOW RD. Auburn, CA 95062 |
| Product Code | DXH |
| CFR Regulation Number | 870.2920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-05-12 |
| Decision Date | 1995-05-10 |