MLOClass II

Electrocardiograph, Ambulatory, With Analysis Algorithm

21 CFR 870.2800 / Cardiovascular

MLO is the FDA product code for Electrocardiograph, Ambulatory, With Analysis Algorithm, a class II device type, regulated under 21 CFR 870.2800. As of 2026-09-10, FDA records hold 32 510(k) clearances under this code, the most recent dated 2025-03-21, and 2 recalls.

Classification record

Product code: MLO
Device name: Electrocardiograph, Ambulatory, With Analysis Algorithm
Regulation: 21 CFR 870.2800
Device class: Class II
Review panel: Cardiovascular
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 33
Ingested recalls: 2

Clearances, product code MLO

By decision year

33 clearances under product code MLO with a decision year between 1999 and 2026, 2001 the highest year at 6.

Show the numbers

510(k) clearances under FDA product code MLO by decision year
Year	Clearances
1999	2
2000	1
2001	6
2002	1
2003	2
2004	1
2005	4
2006	1
2007	1
2010	1
2011	3
2012	1
2013	2
2014	1
2018	1
2020	2
2024	1
2025	1
2026	1

Applicants with the most clearances

Product code MLO

Applicants holding the most 510(k) clearances under product code MLO
Applicant	Clearances
Agilent Technologies, Inc.	3
Inovise Medical, Inc.	3
Galix Biomedical Instrumentation, Inc.	2
Norav Medical Ltd.	2
Novacor	2
Zymed Medical Instrumentation	2
Biomedical Systems Corp.	1
Bittium Biosignals Ltd.	1
Brentwood Medical Technology Corp.	1
Cardiocalm SRL	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 25 companies shown, in name order