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FDA 510(k) Application Details - K080173
Device Classification Name
Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)
More FDA Info for this Device
510(K) Number
K080173
Device Name
Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)
Applicant
LARSEN & TOUBRO LIMITED
1051 PERIMETER DRIVE
SUITE 470
SCHAUMBURG, IL 60173 US
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Contact
S.B. BHOSALE
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Regulation Number
870.2300
More FDA Info for this Regulation Number
Classification Product Code
MWI
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More FDA Info for this Product Code
Date Received
01/24/2008
Decision Date
02/08/2008
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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