FDA 510(k) Application Details - K001333

Device Classification Name Detector And Alarm, Arrhythmia

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510(K) Number K001333
Device Name Detector And Alarm, Arrhythmia
Applicant AGILENT TECHNOLOGIES DEUTSCHLAND GMBH
HERRENBERGER ST. 130
BOEBLINGEN
BOEBLINGEN, 71034 DE
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Contact EGON PFEIL
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Regulation Number 870.1025

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Classification Product Code DSI
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Date Received 04/27/2000
Decision Date 05/17/2000
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



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