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FDA 510(k) Application Details - K031074
Device Classification Name
Electrocardiograph,Ambulatory(Without Analysis)
More FDA Info for this Device
510(K) Number
K031074
Device Name
Electrocardiograph,Ambulatory(Without Analysis)
Applicant
DATRIX
340 STATE PLACE
ESCONDIDO, CA 92029 US
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Contact
LAUREN M LUHMANN
Other 510(k) Applications for this Contact
Regulation Number
870.2800
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Classification Product Code
MWJ
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More FDA Info for this Product Code
Date Received
04/04/2003
Decision Date
10/15/2003
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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