FDA 510(k) Application Details - K971910

Device Classification Name Detector And Alarm, Arrhythmia

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510(K) Number K971910
Device Name Detector And Alarm, Arrhythmia
Applicant HEWLETT-PACKARD GMBH
SCHICKARD STRASSE 4
BOEBLINGEN
WUERTTEMBERG 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 05/23/1997
Decision Date 03/23/1998
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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