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MLO

Electrocardiograph, Ambulatory, With Analysis Algorithm

Product code
MLO
Device name
Electrocardiograph, Ambulatory, With Analysis Algorithm
Device class
Class 2
21 CFR
21 CFR 870.2800
Medical specialty
Cardiovascular
Marketing pathway
510(K)
510(k) clearances (last 3 years)
2
Summaries archived here
2 (direct download)
510(k) clearances (all years, FDA)
32 (all years; only the last 3 years are listed here)

510(k) clearances, last 3 years (2)

Last three years. Most recent: 2025-03-21.

NumberDecision dateApplicantDevice nameSummary
K2418902025-03-21Philips Medizin Systeme Böblingen GmbHPhilips Holter Analysis SystemPDF
K2407942024-11-08Fourth Frontier Technologies Pvt, Ltd.Frontier X PlusPDF

2 summaries are archived here for direct download.

Official FDA classification page: MLO
Classification and pathway per current FDA publications. Data from openFDA (CC0).