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FDA 510(k) Application Details - K083229
Device Classification Name
Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)
More FDA Info for this Device
510(K) Number
K083229
Device Name
Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)
Applicant
L.D. TECHNOLOGY, LLC
11459 NW 34 STREET
MIAMI, FL 33178 US
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Contact
RICHARD CLEMENT
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Regulation Number
870.2300
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Classification Product Code
MWI
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More FDA Info for this Product Code
Date Received
11/03/2008
Decision Date
02/23/2009
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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