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FDA 510(k)

Frontier X Plus

K-Number: K240794 · 2024-11-08

ApplicantFourth Frontier Technologies Pvt, Ltd.
Decision Date2024-11-08
Product CodeMLO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Frontier X Plus is the device name listed in this FDA 510(k) record. The listed applicant is Fourth Frontier Technologies Pvt, Ltd.. It received FDA 510(k) clearance on 2024-11-08 under 510(k) number K240794. The device is classified under product code MLO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Frontier X Plus?

Frontier X Plus is a medical device that received FDA 510(k) clearance on 2024-11-08. The listed applicant is Fourth Frontier Technologies Pvt, Ltd.. The 510(k) number is K240794.

When did Frontier X Plus receive FDA 510(k) clearance?

Frontier X Plus received FDA 510(k) clearance on 2024-11-08, under 510(k) number K240794.

Who is the listed applicant for Frontier X Plus?

The FDA 510(k) record lists Fourth Frontier Technologies Pvt, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Frontier X Plus?

The FDA product code for Frontier X Plus is MLO.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07772817Feasibility and Usability of a Chest-Strap Ambulatory ECG Monitor in Active Individuals in Comparison With a Traditional Ambulatory ECG Patch Monitor (MoMe ARC)RECRUITING

Related Devices (Code: MLO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K241890Philips Holter Analysis SystemPhilips Medizin Systeme Böblingen GmbHK200833RX-1 Rhythm Express Remote Cardiac Monitoring SystemVivaQuant, Inc.K193177CER-SCardiocalmK182030Faros MobileBittium Biosignals , Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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