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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K991735
Device Name MAC SERIES ELECTROCARDIOGRAPHS INCLUDING MAC 5000, MAC PC, MAC 6, MAC VU, MAC 8 ELECTROCARDIOGRAPHS
Applicant
General Electric Medical Systems Information Techn
8200 W. Tower Ave.
Milwaukee,  WI  53223
Applicant Contact DAVID WAHLIG
Correspondent
General Electric Medical Systems Information Techn
8200 W. Tower Ave.
Milwaukee,  WI  53223
Correspondent Contact DAVID WAHLIG
Classification Product Code
LOS
Subsequent Product Codes
DPS   DQK   DXH  
Date Received05/21/1999
Decision Date 08/19/1999
Decision Substantially Equivalent (SESE)
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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