FDA 510(k) Application Details - K042560

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

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510(K) Number K042560
Device Name Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)
Applicant LARSEN & TOUBRO LIMITED
1821 WALDEN OFFICE SQUARE
SUITE 400
SCHAUMBURG, IL 60173 US
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Contact HARRY GUGNANI
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Regulation Number 870.2300

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Classification Product Code MWI
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Date Received 09/21/2004
Decision Date 10/06/2004
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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