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FDA 510(k) Application Details - K110569
Device Classification Name
Electrocardiograph, Ambulatory, With Analysis Algorithm
More FDA Info for this Device
510(K) Number
K110569
Device Name
Electrocardiograph, Ambulatory, With Analysis Algorithm
Applicant
INOVISE MEDICAL, INC.
8770 SW NIMBUS AVENUE
SUITE D
BEAVERTON, OR 97008-7196 US
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Contact
EARL ANDERSON
Other 510(k) Applications for this Contact
Regulation Number
870.2800
More FDA Info for this Regulation Number
Classification Product Code
MLO
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/28/2011
Decision Date
10/24/2011
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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