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FDA 510(k) Application Details - K032882
Device Classification Name
Electrocardiograph,Ambulatory(Without Analysis)
More FDA Info for this Device
510(K) Number
K032882
Device Name
Electrocardiograph,Ambulatory(Without Analysis)
Applicant
RECOM MANAGED SYSTEMS, INC.
4705 LAUREL CANYON BLVD.
SUITE 203
VALLEY VILLAGE, CA 91607 US
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Contact
WILLAM R MATTHEWS
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
09/15/2003
Decision Date
01/28/2004
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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