The following data is part of a premarket notification filed by Zymed Medical Instrumentation with the FDA for Zymed Telemetry System, Model Easi View.
Device ID | K984089 |
510k Number | K984089 |
Device Name: | ZYMED TELEMETRY SYSTEM, MODEL EASI VIEW |
Classification | Detector And Alarm, Arrhythmia |
Applicant | ZYMED MEDICAL INSTRUMENTATION 20 NORTH AVIADOR ST. Camarillo, CA 93010 |
Contact | Dudley Harris |
Correspondent | Dudley 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 | 1998-11-16 |
Decision Date | 1999-02-16 |
Summary: | summary |