# K062088: Premier 11 Holter

- Pathway: 510(k) (Special)
- Applicant: Diagnostic Monitoring Software
- Decided: Aug 25, 2006 after 32 days
- Product code: MLO (Electrocardiograph, Ambulatory, With Analysis Algorithm)
- Device class: 2
- Regulation: 21 CFR 870.2800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K871344 (1987). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K911615: Holter 24-Hour Ecg System, Model Number: DMS 300, Diagnostic Monitoring Software (1992) Summary page 1.
- K031466: Iqmark Digital Holter, Brentwood Medical Technology Corp. (2003) Summary page 1.

## Indications for use
The indications for use for 24-hour ambulatory ECG for this modified Premier 11 software and the listed predicate devices are for ECG evaluation of, but limited, to typical symptoms of chest pains, palpitations, dizziness, shortness of breath, and pacemaker. More specifically, indications for use include the following: . Assessment of symptoms that may be related to rhythm disturbances of the heart in patients from pediatric to adult age; such as, palpitations. • Assessment of risk in patients with or without symptoms or arrhythmia; such as, patients with symptomatic or asymptomatic idiopathic hypertrophic cardiomyopathy and postmyocardial infarction patients with left ventricular dysfunction- • Assessment of efficacy of anti-arrhythmic therapy. * Assessment of pacemaker function. .Detection of transient ST Depression, as well as Prinzmetal ST Elevation.

Source page: https://510kreport.com/device/K062088
Methodology: https://510kreport.com/methodology