# K984465: Oxyconalpha with Option Ecg

- Pathway: 510(k) (Traditional)
- Applicant: Erich Jaeger B.V.
- Decided: Oct 27, 1999 after 315 days
- Product code: LOS
- 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
The OxyconAlpha with option ECG is a software-driven, medical device for exercise measurements, including ECG ST Segment Analysis and/or ECG Stress Analysis. It measures the human response fo increasing workloads with emphasis on the gas exchange parameters. Measurements include ventilation, oxygen uptake, carbon dioxide excretion, heart rate and derived parameters. The results of the tests, including the ECG wave forms, can be viewed on the computer screen and can be printed during the test. The test results can be saved on the computer hard disk for further referral or report generation purposes. The OxyconAlpha with option ECG interfaces to a testsubject via a mouthpiece or a face mask and ECG electrodes. The OxyconAlpha with option ECG interfaces to a peripheral ergometer or treadmill. The patient population is 4 age and older. The OxyconAlpha with option ECG is capable of performing computerized ECG interpretation during resting condition. The intended use locations are either in a physician office, hospital exercise rehabilitation facilities. or similar areas. It is intanded to bo ueod by or on the order of a physician or similar qualified health care professional. This device is intended for use in the hospital environment, physician’s office, or similar settings. This device is not intended for home use.

Source page: https://510kreport.com/device/K984465
Methodology: https://510kreport.com/methodology