FDA 510(k) Application Details - K093017

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

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510(K) Number K093017
Device Name Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)
Applicant LARSEN & TOUBRO LIMITED
1468 HARWELL AVE.
CROFTON, MD 21114 US
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Contact E.J. Smith
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Regulation Number 870.2300

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Classification Product Code MWI
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Date Received 09/29/2009
Decision Date 04/29/2010
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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