FDA 510(k) Application Details - K010048

Device Classification Name Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)

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510(K) Number K010048
Device Name Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)
Applicant AGILENT TECHNOLOGIES, INC.
3000 MINUTEMAN RD.
ANDOVER, MA 01810-1099 US
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Contact MIKE HUDON
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Regulation Number 870.2300

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Classification Product Code MWI
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Date Received 01/05/2001
Decision Date 02/01/2001
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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