MAC 7 - 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 7 - Resting Ecg Analysis System.

Pre-market Notification Details

Device IDK203786
510k NumberK203786
Device Name:MAC 7 - Resting ECG Analysis System
ClassificationElectrocardiograph
Applicant GE Medical Systems Information Technologies, Inc. 9900 Innovation Drive Wauwatosa,  WI  53226
ContactLee Bush
CorrespondentLee Bush
GE Medical Systems Information Technologies, Inc. 9900 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 Received2020-12-28
Decision Date2021-04-30

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