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FDA 510(k) Application Details - K052119
Device Classification Name
Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)
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510(K) Number
K052119
Device Name
Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)
Applicant
MAMMENDORFER INSTITUTE FOR PHYSICS & MEDICINE GMBH
13605 WEST 7TH AVE.
GOLDEN, CO 80401 US
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ROBERT N CLARK
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Regulation Number
870.2300
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Classification Product Code
MWI
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Date Received
08/04/2005
Decision Date
01/03/2006
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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