FDA 510(k) Application Details - K011824

Device Classification Name Detector And Alarm, Arrhythmia

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510(K) Number K011824
Device Name Detector And Alarm, Arrhythmia
Applicant AGILENT TECHNOLOGIES, INC.
3000 MINUTEMAN RD.
ANDOVER, MA 01810-1099 US
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Contact DENISE HALEY
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Regulation Number 870.1025

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Classification Product Code DSI
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Date Received 06/11/2001
Decision Date 07/02/2001
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review

FDA Source Information for K011824


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