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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 K960321
Device Name CARDIOCATH CATHETERIZATION LAB SYSTEM
Applicant
Prucka Engineering, Inc.
8050 El Rio
Houston,  TX  77054
Applicant Contact MATTHEW W PRUCKA
Correspondent
Prucka Engineering, Inc.
8050 El Rio
Houston,  TX  77054
Correspondent Contact MATTHEW W PRUCKA
Regulation Number870.2340
Classification Product Code
DPS  
Date Received01/22/1996
Decision Date 08/21/1996
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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