FDA 510(k) Application Details - K934913

Device Classification Name Detector And Alarm, Arrhythmia

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510(K) Number K934913
Device Name Detector And Alarm, Arrhythmia
Applicant CARDIAC TELECOM CORP.
COLUMBIA SQUARE
555 THIRTEENTH STREET N.W.
WASHINGTON, DC US
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Contact JONATHAN S KAHAN
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Regulation Number 870.1025

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Classification Product Code DSI
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Date Received 10/15/1993
Decision Date 06/05/1995
Decision SE - Substantially Equivalent
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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