# K990956: Biosensor Holter Monitor System Software, Model 1005

- Pathway: 510(k) (Traditional)
- Applicant: Biosensor Corp.
- Decided: Jun 14, 1999 after 84 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. The FDA summary names no predicate by number.

## Indications for use
Ambulatory (Holter) ECG intended use: The Biosensor CMS Holter Analysis system is intended for patients requiring ambulatory (Holter) monitoring from 1 to 48 hours. Such monitoring is most frequently used for the indications below, 1. Evaluation of symptoms suggesting archythmia 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 a patient’s response after resuming occupational or recreational activities (e.g., after M.I. or cardiac surgery.) 5. Clinical and epidemiological research studies. 6. Evaluation of patients with pacemakers 7. Reporting of time and frequency domain heart rate variability 8. Reporting of QT Interval.

Source page: https://510kreport.com/device/K990956
Methodology: https://510kreport.com/methodology