# K946205: Cardiovit at-1, P-80

- Pathway: 510(k) (Traditional)
- Applicant: Schiller America, Inc.
- Decided: Mar 16, 1995 after 85 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.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K961798: CT 200 Electrocardiograph (1998), 0 descendants of its own
- K981951: CT 100 Electrocardiograph (1998), 0 descendants of its own

Source page: https://510kreport.com/device/K946205
Methodology: https://510kreport.com/methodology