FDA 510(k) Application Details - K140847

Device Classification Name	Electrocardiograph, Ambulatory, With Analysis Algorithm   More FDA Info for this Device
510(K) Number	K140847
Device Name	Electrocardiograph, Ambulatory, With Analysis Algorithm
Applicant	LABTECH KFT. VAGU 4 DEBRECEN 4031 HU Other 510(k) Applications for this Company
Contact	ZSOLT KATONAI 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	04/03/2014
Decision Date	12/05/2014
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