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FDA 510(k) Application Details - K103686
Device Classification Name
Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)
More FDA Info for this Device
510(K) Number
K103686
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
Other 510(k) Applications for this Contact
Regulation Number
870.2300
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Classification Product Code
MWI
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/17/2010
Decision Date
03/15/2011
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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