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510(k) K240794

Device
Frontier X Plus
Applicant
Fourth Frontier Technologies Pvt, Ltd.
510(k) number
K240794
Product code
MLO
Decision
Substantially Equivalent (SESE)
Decision date
2024-11-08
Date received
2024-03-22
Regulation
870.2800
Classification name
Electrocardiograph, Ambulatory, With Analysis Algorithm
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Manav Bhushan
Address
2nd And 3rd Floor, # 794, 12th Main, 1st Cross, Hal, 2nd Stage, Indiranagar Bengaluru IN 560038 560038

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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