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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 K913374
Device Name CARDIO PERFECT, CARDIO PERFECT MD
Applicant
Cardio Control BV
Partrijsweg 72
2289 Ex Rijswijk
The Netherlands,  NL
Applicant Contact VAN LUIJK
Correspondent
Cardio Control BV
Partrijsweg 72
2289 Ex Rijswijk
The Netherlands,  NL
Correspondent Contact VAN LUIJK
Regulation Number870.2340
Classification Product Code
DPS  
Date Received07/29/1991
Decision Date 01/23/1992
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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