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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrocardiograph, Ambulatory, With Analysis Algorithm
510(k) Number K240794
Device Name Frontier X Plus
Applicant
Fourth Frontier Technologies Pvt Ltd
2nd and 3rd Floor, No. 794, 12th Main, 1st Cross, HAL,
2nd Stage, Indiranagar
Bengaluru,  IN 560038
Applicant Contact Manav Bhushan
Correspondent
Fourth Frontier Technologies Pvt Ltd
2nd and 3rd Floor, No. 794, 12th Main, 1st Cross, HAL,
2nd Stage, Indiranagar
Bengaluru,  IN 560038
Correspondent Contact Manav Bhushan
Regulation Number870.2800
Classification Product Code
MLO  
Subsequent Product Codes
DPS   DXH  
Date Received03/22/2024
Decision Date 11/08/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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