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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Network And Communication, Physiological Monitors
510(k) Number K994430
Device Name IMPACT.WF MOBILE WAVEFORM RECEIVING SYSTEM
Applicant
General Electric Medical Systems Information Techn
8200 W. Tower Ave.
Milwaukee,  WI  53223
Applicant Contact KAREN WEBB
Correspondent
General Electric Medical Systems Information Techn
8200 W. Tower Ave.
Milwaukee,  WI  53223
Correspondent Contact KAREN WEBB
Regulation Number870.2300
Classification Product Code
MSX  
Date Received12/29/1999
Decision Date 03/28/2000
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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