The following data is part of a premarket notification filed by Telescan Medical Systems with the FDA for The Telescan C.a.r.e. System.
| Device ID | K871587 |
| 510k Number | K871587 |
| Device Name: | THE TELESCAN C.A.R.E. SYSTEM |
| Classification | Recorder, Magnetic Tape, Medical |
| 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 | DSH |
| CFR Regulation Number | 870.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-04-24 |
| Decision Date | 1987-08-12 |