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FDA 510(k) Application Details - K051628
Device Classification Name
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
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510(K) Number
K051628
Device Name
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Applicant
Draeger Medical Systems, Inc.
16 ELECTRONICS AVE.
DANVERS, MA 01923 US
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Contact
PENELOPE H GRECO
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Regulation Number
870.1025
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Classification Product Code
MHX
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More FDA Info for this Product Code
Date Received
06/20/2005
Decision Date
07/20/2005
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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