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 Other 510(k) Applications for this Company
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 Other 510(k) Applications for this Device   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