# K961798: CT 200 Electrocardiograph

- Pathway: 510(k) (Traditional)
- Applicant: Macquarie Medical Systems
- Decided: Aug 5, 1998 after 818 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 K946205 (1995). 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)
- K946205: Cardiovit at-1, P-80, Schiller America, Inc. (1995) Summary page 1.
- (no number) AT-5/6 series of devices: named in the summary without a submission number

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

Source page: https://510kreport.com/device/K961798
Methodology: https://510kreport.com/methodology