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FDA 510(k) Application Details - K182030
Device Classification Name
Electrocardiograph, Ambulatory, With Analysis Algorithm
More FDA Info for this Device
510(K) Number
K182030
Device Name
Electrocardiograph, Ambulatory, With Analysis Algorithm
Applicant
Bittium Biosignals Ltd.
Pioneerinkatu 6
Kuopio FI-70800 FI
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Contact
Taneli Vaaraniemi
Other 510(k) Applications for this Contact
Regulation Number
870.2800
More FDA Info for this Regulation Number
Classification Product Code
MLO
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More FDA Info for this Product Code
Date Received
07/30/2018
Decision Date
11/08/2018
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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