DeviceClearance

Product code MLO— Cardiovascular

2010 PLUS HOLTER FOR WINDOWS

Classification name
Electrocardiograph, Ambulatory, With Analysis Algorithm
Device class
Class 2
Regulation
21 CFR 870.2800
Advisory panel
Cardiovascular
Total cleared
33
First cleared
Most recent

Market context for product code MLO

FDA has cleared 33 devices under product code MLO between 1999 and 2026, filed by 26 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

last 15 years

Top applicants under product code MLO

Recent clearances under product code MLO

Data sourced from openFDA. This site is unofficial and independent of the FDA.