MAC VU360 Resting ECG Analysis System

Electrocardiograph

GE Medical Systems Information Technologies, Inc.

The following data is part of a premarket notification filed by Ge Medical Systems Information Technologies, Inc. with the FDA for Mac Vu360 Resting Ecg Analysis System.

Pre-market Notification Details

Device IDK173830
510k NumberK173830
Device Name:MAC VU360 Resting ECG Analysis System
ClassificationElectrocardiograph
Applicant GE Medical Systems Information Technologies, Inc. 9900 West Innovation Drive Wauwatosa,  WI  53226
ContactMarcella Entwisle
CorrespondentMarcella Entwisle
GE Medical Systems Information Technologies, Inc. 9900 West Innovation Drive Wauwatosa,  WI  53226
Product CodeDPS  
Subsequent Product CodeDQK
Subsequent Product CodeDXH
CFR Regulation Number870.2340 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-12-18
Decision Date2018-09-18
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00840682125499 K173830 000
00840682125307 K173830 000
00840682125291 K173830 000

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