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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Detector And Alarm, Arrhythmia
510(k) Number K935732
Device Name CARDIO PERFECT ST 2001
Applicant
Cardio Control BV
Partrijsweg 72
2289 Ex Rijswijk
The Netherlands,  NL
Applicant Contact DICK F VAN LUIJK
Correspondent
Cardio Control BV
Partrijsweg 72
2289 Ex Rijswijk
The Netherlands,  NL
Correspondent Contact DICK F VAN LUIJK
Regulation Number870.1025
Classification Product Code
DSI  
Date Received12/01/1993
Decision Date 04/04/1996
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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