FDA 510(k) Application Details - K935732

Device Classification Name Detector And Alarm, Arrhythmia

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510(K) Number K935732
Device Name Detector And Alarm, Arrhythmia
Applicant CARDIO CONTROL BV
PARTRIJSWEG 72
2289 EX RIJSWIJK
THE NETHERLANDS NL
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Contact DICK F VAN LUIJK
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Regulation Number 870.1025

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Classification Product Code DSI
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Date Received 12/01/1993
Decision Date 04/04/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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