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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 K133622
Device Name MAC 2000 ECG ANALYSIS SYSTEM
Applicant
Wipro GE Healthcare
8200 W. Tower Ave.
Milwaukee,  WI  53223
Applicant Contact DOUGLAS KENTZ
Correspondent
Wipro GE Healthcare
8200 W. Tower Ave.
Milwaukee,  WI  53223
Correspondent Contact DOUGLAS KENTZ
Regulation Number870.2340
Classification Product Code
DPS  
Subsequent Product Codes
DQK   DXH  
Date Received11/22/2013
Decision Date 01/23/2014
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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