FDA 510(k) Application Details - K081552

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

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510(K) Number K081552
Device Name Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)
Applicant LARSEN & TOUBRO LIMITED
KIADB INDUSTRIAL AREA
HEBBAL, HOTTAGALLI
MYSORE, KARNATAKA 570 018 IN
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Contact A B DESHPANDE
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Regulation Number 870.2300

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Classification Product Code MWI
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Date Received 06/03/2008
Decision Date 07/31/2008
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 Y
Expedited Review



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