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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 K000645
Device Name GE MARQUETTE MEDICAL SYSTEMS PRUCKA CARDIOLAB CATH SYSTEM, VERSION 1.11
Applicant
General Electric Medical Systems Information Techn
13000 Executive Dr.
Sugarland,  TX  77478
Applicant Contact IAN MCDONALD
Correspondent
General Electric Medical Systems Information Techn
13000 Executive Dr.
Sugarland,  TX  77478
Correspondent Contact IAN MCDONALD
Regulation Number870.2340
Classification Product Code
DPS  
Date Received02/25/2000
Decision Date 05/24/2000
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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