The following data is part of a premarket notification filed by Agilent Technologies with the FDA for Zymed Telemetry Monitor Model T8010 (preliminary).
Device ID | K924672 |
510k Number | K924672 |
Device Name: | ZYMED TELEMETRY MONITOR MODEL T8010 (PRELIMINARY) |
Classification | Detector And Alarm, Arrhythmia |
Applicant | AGILENT TECHNOLOGIES 20 NORTH AVIADOR ST. Camarillo, CA 93010 |
Contact | Jose R Gonzalez |
Correspondent | Jose R Gonzalez AGILENT TECHNOLOGIES 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 | 1992-09-16 |
Decision Date | 1992-12-15 |