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FDA 510(k) Application Details - K033600
Device Classification Name
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
More FDA Info for this Device
510(K) Number
K033600
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
Other 510(k) Applications for this Contact
Regulation Number
870.1025
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Classification Product Code
MHX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/14/2003
Decision Date
12/11/2003
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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