# K963578: PC Based Electrocardiograph System (PC-Ecg)

- Pathway: 510(k) (Traditional)
- Applicant: Intl. Products, Inc.
- Decided: Jun 30, 1997 after 297 days
- Product code: DPS (Electrocardiograph)
- Device class: 2
- Regulation: 21 CFR 870.2340
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) CC Cardio-Card (Nasiff Associates): named in the summary without a submission number

## Most influential descendants
- K992584: PE 501 PC-Ecg Monitor (2000), 0 descendants of its own

## Indications for use
The PC-ECG systém is a fully featured, non-invasive, rcal-time, 12-lead ECG system capablc of recording, display and storage of data using a PC (personal computer). It is used in doctor's offices by cardiologists to record the clectrical heart signals (electrocardiogram) of patients in order to detect abnormal heart conditions. Patients are hooked up to the PC-ECG system via cables connected to the extremities and the chest using rubberized disks which contain in a small central depression a paste. Tldevicc is for prescription use only.

Source page: https://510kreport.com/device/K963578
Methodology: https://510kreport.com/methodology