M2376A DEVICELINK SYSTEM

Monitor, Physiological, Patient (without 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 M2376a Devicelink System.

Pre-market Notification Details

Device IDK003107
510k NumberK003107
Device Name:M2376A DEVICELINK SYSTEM
ClassificationMonitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)
Applicant AGILENT TECHNOLOGIES, INC. 3000 MINUTEMAN RD. Andover,  MA  01810 -1099
ContactMike Hudon
CorrespondentMike Hudon
AGILENT TECHNOLOGIES, INC. 3000 MINUTEMAN RD. Andover,  MA  01810 -1099
Product CodeMWI  
CFR Regulation Number870.2300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-10-04
Decision Date2000-10-19

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