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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 K993414
Device Name PRUCKA ENGINEERING INC. CARDIOLAB EP SYSTEM,VERSION 4.2
Applicant
PRUCKA ENGINEERING, INC.
13000 EXECUTIVE DR.
SUGAR LAND,  TX  77478
Applicant Contact MATTHEW W PRUCKA
Correspondent
PRUCKA ENGINEERING, INC.
13000 EXECUTIVE DR.
SUGAR LAND,  TX  77478
Correspondent Contact MATTHEW W PRUCKA
Regulation Number870.2340
Classification Product Code
DPS  
Date Received10/12/1999
Decision Date 04/07/2000
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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