VIRIDIA INFORMATION CENTER SOFTWARE FOR M3150A AND M3153A, VIRIDIA TELEMETRY SYSTEM TRANSMITTER

Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)

AGILENT TECHNOLOGIES, INC.

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.

Pre-market Notification Details

Device IDK000854
510k NumberK000854
Device Name:VIRIDIA INFORMATION CENTER SOFTWARE FOR M3150A AND M3153A, VIRIDIA TELEMETRY SYSTEM TRANSMITTER
ClassificationMonitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
Applicant AGILENT TECHNOLOGIES, INC. 3000 MINUTEMAN RD. Andover,  MA  01810 -1099
ContactDave Osborn
CorrespondentDave Osborn
AGILENT TECHNOLOGIES, INC. 3000 MINUTEMAN RD. Andover,  MA  01810 -1099
Product CodeMHX  
Subsequent Product CodeDSI
Subsequent Product CodeMLD
CFR Regulation Number870.1025 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-03-16
Decision Date2000-04-10

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