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FDA 510(k) Application Details - K990125
Device Classification Name
Detector And Alarm, Arrhythmia
More FDA Info for this Device
510(K) Number
K990125
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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More FDA Info for this Product Code
Date Received
01/13/1999
Decision Date
01/29/1999
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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