# K090895: Ekg-Plus II Software

- Pathway: 510(k) (Traditional)
- Applicant: Bionet Co., Ltd.
- Decided: Aug 26, 2009 after 149 days
- Product code: LOS
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K974352 (1998). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974352: Cardioview 3000 Software, Micromedical, Inc. (1998) Summary page 1.

## Indications for use
EKG-PLUS II Software is a Window-based program intended to receive, display, store and print out in network environment the ECG data monitored, recorded and analyzed by a Bionet's ECG device- CardioCare-2000 (Formerly, CardioCare EKG-2000) or CardioTouch-3000. The software can also store the ECG data as JPEG file.

Source page: https://510kreport.com/device/K090895
Methodology: https://510kreport.com/methodology