Cleared Traditional

Frontier X Plus

K240794 · Fourth Frontier Technologies Pvt, Ltd. · Cardiovascular

Nov 2024

Decision

231d

Days

Class 2

Risk

About This 510(k) Submission

K240794 is an FDA 510(k) clearance for the Frontier X Plus, a Electrocardiograph, Ambulatory, With Analysis Algorithm (Class II — Special Controls, product code MLO), submitted by Fourth Frontier Technologies Pvt, Ltd. (Bengaluru, IN). The FDA issued a Cleared decision on November 8, 2024, 231 days after receiving the submission on March 22, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2800.

Submission Details

510(k) Number	K240794 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 22, 2024
Decision Date	November 08, 2024
Days to Decision	231 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF