# K971670: 3 Channel Digital Ambulatory Ecg Recorder

- Pathway: 510(k) (Traditional)
- Applicant: Galix Biomedical Instrumentation, Inc.
- Decided: Jan 29, 1998 after 268 days
- Product code: DSH (Recorder, Magnetic Tape, Medical)
- 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Electrocardiographic recording to document a patient’s arrhythmia has had widespread application as a non invasive tool in cardiology. A patient’s arrhythmia may be documented by a simple electrocardiogram; however the use of techniques with longer monitoring periods, usually for 24 hours or more (Holter monitoring), increases the likelihood of documenting the arrhythmia. Since the original description by Dr Norman Holter in the 1950 s, Holter monitoring or continuous ambulatory electrocardiographic monitoring has been a useful technique for patients with cardiac arrhythmias. Indications for Holter monitoring are listed in Table I. The primary use of ambulatory monitoring is for the evaluation of cases of suspected cardiac rhythm disturbances. Since these arrhythmias can be episodic, detection of complex ventricular arrhythmias will vary, depending of the duration of the recording. A 24 - hour Holter recording permits the recording of cardiac rhythm during both sleep and awake states. Thus the variation of arrhythmias during waking hours and during physical and mental stress can be demonstrated. TABLE I: Indications for Holter monitoring 1 - Evaluation of suspected or known cardiac rhythm disorders. 2 - Evaluation of symptoms suggestive of an arrhythmia disorder. 3 - Evaluation of clinical syndromes in which arrhythmias may increase the risk of sudden death. 4 - Evaluation of pacemaker function. 5 - Evaluation of chest pam Holter monitors are used in a serial fashion to judge the efficacy of antiarrthythmic drug treatment. Holter monitors are frequently used as part of diagnostic studies to determine whether a new cardioactive drug has either antiarrhythmic or proarrhythmic effects. Because of spontaneous variability of a patient's arrhythmia these studies are often limited and should be viewed with caution. Studies that have used longer monitoring periods may be more accurate. Holter monitors may also be used for screening patients with symptoms suggestive of sinus node or AV node conduction problems. Holter monitoring can be useful in correlating episodes of chest pain with diagnostic ST segment abnormalities. Holter recordings are also used to screen patients who have clinical syndromes in which the presence of an arrhythmia may increase the risk of sudden death. Such situations-include: theperiod-after myocardfal -infarction, Congestive heart failure and dilated cardiomyopathy, hypertrophic obstructive cardiomyopathy, and the congenital prolonged QT syndrome. Holter recordings may also be useful in screening for arrhythmias in patients with the mitral valve prolapse syndrome and in those recovering from coronary artery bypass surgery. Holter monitoring can aiso be used to screen patients with symptomatic or asymptomatic Wolff - Parkinson - White syndrome. Patients who have suspected pacemaker malfunction may aiso require long-term monitoring to document an intermittent episode of failure to capture or failure to sense. These abnormalities and oversensing problems may be easily documented during ambulatory monitoring.

Source page: https://510kreport.com/device/K971670
Methodology: https://510kreport.com/methodology