FDA 510(k) Application Details - K991773

Device Classification Name Detector And Alarm, Arrhythmia

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510(K) Number K991773
Device Name Detector And Alarm, Arrhythmia
Applicant HEWLETT-PACKARD GMBH
HERRENBERGER STR. 110-140
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 05/25/1999
Decision Date 06/07/1999
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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