# K981951: CT 100 Electrocardiograph

- Pathway: 510(k) (Traditional)
- Applicant: Macquarie Medical Systems
- Decided: Jul 28, 1998 after 90 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
Longest line of descent: 1 generation back to K904032 (1991). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K946205: Cardiovit at-1, P-80, Schiller America, Inc. (1995) Summary page 1.
- K904032: Elite II Electrocardiograph, Burdick Corp. (1991) Summary page 1.

## Indications for use
The device is intended for use as a diagmostic device which receives, records, and produces a visual display of the electrical signal produced by the heart.

Source page: https://510kreport.com/device/K981951
Methodology: https://510kreport.com/methodology