FDA 510(k) Application Details - K240794

Device Classification Name	Electrocardiograph, Ambulatory, With Analysis Algorithm   More FDA Info for this Device
510(K) Number	K240794
Device Name	Electrocardiograph, Ambulatory, With Analysis Algorithm
Applicant	Fourth Frontier Technologies Pvt Ltd 2nd and 3rd Floor, No. 794, 12th Main, 1st Cross, HAL, 2nd Stage, Indiranagar Bengaluru 560038 IN Other 510(k) Applications for this Company
Contact	Manav Bhushan 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	03/22/2024
Decision Date	11/08/2024
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