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FDA 510(k) Application Details - K964122
Device Classification Name
Detector And Alarm, Arrhythmia
More FDA Info for this Device
510(K) Number
K964122
Device Name
Detector And Alarm, Arrhythmia
Applicant
HEWLETT-PACKARD CO.
3000 MINUTEMAN RD.
ANDOVER, MA 01810 US
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Contact
RAY STELTING
Other 510(k) Applications for this Contact
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
10/15/1996
Decision Date
01/08/1997
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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