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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Echocardiograph
510(k) Number K871555
Device Name RT5000 W/QUANTI. SPEC. DOPPLER, CW DOPP. MODIFICA.
Applicant
General Electric Co.
P.O. Box 414
Milwaukee,  WI  53201
Applicant Contact LARRY KROGER
Correspondent
General Electric Co.
P.O. Box 414
Milwaukee,  WI  53201
Correspondent Contact LARRY KROGER
Regulation Number870.2330
Classification Product Code
DXK  
Date Received04/22/1987
Decision Date 03/02/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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