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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrocardiograph
510(k) Number K203786
Device Name MAC 7 - Resting ECG Analysis System
Applicant
Ge Medical Systems Information Technologies, Inc.
9900 Innovation Dr.
Wauwatosa,  WI  53226
Applicant Contact Lee Bush
Correspondent
Ge Medical Systems Information Technologies, Inc.
9900 Innovation Dr.
Wauwatosa,  WI  53226
Correspondent Contact Lee Bush
Regulation Number870.2340
Classification Product Code
DPS  
Subsequent Product Codes
DQK   DXH  
Date Received12/28/2020
Decision Date 04/30/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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