The following data is part of a premarket notification filed by Zymed Medical Instrumentation with the FDA for Zymed Telemetry System; Model T8010.
| Device ID | K951370 |
| 510k Number | K951370 |
| Device Name: | ZYMED TELEMETRY SYSTEM; MODEL T8010 |
| Classification | Detector And Alarm, Arrhythmia |
| Applicant | ZYMED MEDICAL INSTRUMENTATION 20 NORTH AVIADOR ST. Camarillo, CA 93010 |
| Contact | J. D Harris |
| Correspondent | J. D Harris ZYMED MEDICAL INSTRUMENTATION 20 NORTH AVIADOR ST. Camarillo, CA 93010 |
| Product Code | DSI |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-03-27 |
| Decision Date | 1995-10-06 |