# K023034: Cardiotouch-3000

- Pathway: 510(k) (Special)
- Applicant: Bionet Company, Ltd.
- Decided: Nov 14, 2002 after 63 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 K011328 (2001). 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)
- K011328: Cardio Care Ekg-2000 12-Channel Electrocardiograph, Bionet Company, Ltd. (2001) Summary page 2.

## Indications for use
The CARDIOTOUCH-3000 is intended to be used under the direct supervision of a licensed healthcare practitioner. The CARDIOTOUCH-3000 is intended to be used by trained operators in a hospital or medical professional's facility environment to record ECG signals from surface electrodes. The device is intended to acquire, analyze, display, and record electrocardiographic information from adult population. The device is not intended for home use. The device is not designated for intracardial use.

Source page: https://510kreport.com/device/K023034
Methodology: https://510kreport.com/methodology