# K984263: Ewc:  Ecg II Cable Leadwire System

- Pathway: 510(k) (Abbreviated)
- Applicant: Ewc
- Decided: Feb 2, 1999 after 64 days
- Product code: DSA (Cable, Transducer And Electrode, Patient, (Including Connector))
- Device class: 2
- Regulation: 21 CFR 870.2900
- 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 K770884 (1977). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K771645: Electrocardiographic Cablhs & Lead Wire, Tronomed, Inc. (1977) Summary page 1.
- K771027: Electrocardiographic Patient Cables, Tronomed, Inc. (1977) Summary page 1.
- K770884: Elhctrocardiographic Connecting Wires, Tronomed, Inc. (1977) Summary page 1.

## Indications for use
The EWC: ECG II Cable and Leadwire Systems are reusable electrode cable systems used to transmit signals from patient electrodes (not supplied by EWC) to various electrocardiographic recorders and/or monitors (not supplied by EWC) for both diagnostic and monitoring purposes. The EWC: ECG II Cable and Leadwire System is limited by the indication for use of the connected monitoring or diagnostic equipment. Such equipment is commonly located in hospitals, doctor's offices, emergency vehicles, as well as in home use.

Source page: https://510kreport.com/device/K984263
Methodology: https://510kreport.com/methodology