MUSE CARDIOVASCULAR INFORMATION SYSTEM

Detector And Alarm, Arrhythmia

GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN

The following data is part of a premarket notification filed by General Electric Medical Systems Information Techn with the FDA for Muse Cardiovascular Information System.

Pre-market Notification Details

Device IDK992637
510k NumberK992637
Device Name:MUSE CARDIOVASCULAR INFORMATION SYSTEM
ClassificationDetector And Alarm, Arrhythmia
Applicant GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN 8200 WEST TOWER AVE. Milwaukee,  WI  53223
ContactLaura L Mccomis
CorrespondentLaura L Mccomis
GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN 8200 WEST TOWER AVE. Milwaukee,  WI  53223
Product CodeDSI  
CFR Regulation Number870.1025 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-08-06
Decision Date1999-11-03
Summary:summary

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