The following data is part of a premarket notification filed by Agilent Technologies, Inc. with the FDA for Viridia Information Center Software For M3150a And M3153a, Viridia Telemetry System Transmitter.
Device ID | K000854 |
510k Number | K000854 |
Device Name: | VIRIDIA INFORMATION CENTER SOFTWARE FOR M3150A AND M3153A, VIRIDIA TELEMETRY SYSTEM TRANSMITTER |
Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
Applicant | AGILENT TECHNOLOGIES, INC. 3000 MINUTEMAN RD. Andover, MA 01810 -1099 |
Contact | Dave Osborn |
Correspondent | Dave Osborn AGILENT TECHNOLOGIES, INC. 3000 MINUTEMAN RD. Andover, MA 01810 -1099 |
Product Code | MHX |
Subsequent Product Code | DSI |
Subsequent Product Code | MLD |
CFR Regulation Number | 870.1025 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-03-16 |
Decision Date | 2000-04-10 |