# K974546: Biosensor Holter Monitor System

- Pathway: 510(k) (Traditional)
- Applicant: Biosensor Corp.
- Decided: Mar 4, 1998 after 90 days
- Product code: DQK (Computer, Diagnostic, Programmable)
- Device class: 2
- Regulation: 21 CFR 870.1425
- 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
Caution: Federal law restricts this device to sale by or on the order of a physician. The Biosensor Holter Monitor System is intended for patients requiring ambulatory (Holter) monitoring from 1 to 24 hours. Such monitoring is most frequently used for the indications below. (Portions from Ambulatory Electrocardiograph Recording, Wegner NK, Mock MB, and Relngquist |, Year Book Medical Publishers, 1881.) 1. Evaluation of symptoms suggesting arrhythmia or myocardial ischemia. 2. Evaluation of ECG documenting therapeutic interventions in individual patients or groups of patients. 3. Evaluation of patients for ST segment changes. 4. Evaluation of patient's response after resumning occupational or recreational activities (e.g., after M.|. or cardiac surgery.) 5. Evaluation of clinical syndromes or situations where arrhythmia may increase the risk of sudden death. 6. Clinical and epidemiological research studies.

Source page: https://510kreport.com/device/K974546
Methodology: https://510kreport.com/methodology