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FDA 510(k) Application Details - K012712
Device Classification Name
Electrocardiograph, Ambulatory, With Analysis Algorithm
More FDA Info for this Device
510(K) Number
K012712
Device Name
Electrocardiograph, Ambulatory, With Analysis Algorithm
Applicant
NORAV MEDICAL LTD.
12505 58TH AVE. N.
PLYMOUTH, MN 55442 US
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Contact
STEVE SPRINGROSE
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Regulation Number
870.2800
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Classification Product Code
MLO
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More FDA Info for this Product Code
Date Received
08/14/2001
Decision Date
05/08/2002
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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