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510(k) K240794

Frontier X Plus by Fourth Frontier Technologies Pvt, Ltd. — Product Code MLO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 8, 2024
Date Received
March 22, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrocardiograph, Ambulatory, With Analysis Algorithm
Device Class
Class II
Regulation Number
870.2800
Review Panel
CV
Submission Type

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