MONARCH SYSTEM

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

BAXTER HEALTHCARE CORP.

The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for Monarch System.

Pre-market Notification Details

Device IDK911051
510k NumberK911051
Device Name:MONARCH SYSTEM
ClassificationMonitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
Applicant BAXTER HEALTHCARE CORP. P.O. BOX 11150 Santa Ana,  CA  92711
ContactJack P Douglas
CorrespondentJack P Douglas
BAXTER HEALTHCARE CORP. P.O. BOX 11150 Santa Ana,  CA  92711
Product CodeMHX  
CFR Regulation Number870.1025 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-03-08
Decision Date1991-08-22

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