The following data is part of a premarket notification filed by Telescan Medical Systems with the FDA for Telescan Instant Memory Ecg Recorder Model T-35cm.
| Device ID | K883358 |
| 510k Number | K883358 |
| Device Name: | TELESCAN INSTANT MEMORY ECG RECORDER MODEL T-35CM |
| Classification | Transmitters And Receivers, Electrocardiograph, Telephone |
| Applicant | TELESCAN MEDICAL SYSTEMS 10091 STREETER RD. Auburn, CA 95003 |
| Contact | Stanley Wegner |
| Correspondent | Stanley Wegner TELESCAN MEDICAL SYSTEMS 10091 STREETER RD. Auburn, CA 95003 |
| Product Code | DXH |
| CFR Regulation Number | 870.2920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-08-09 |
| Decision Date | 1988-10-13 |