# K970879: Cardiovit CS-200

- Pathway: 510(k) (Traditional)
- Applicant: Schiller America, Inc.
- Decided: Jun 25, 1997 after 107 days
- Product code: LOS
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
12 later devices descend from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K012226: Monitoring System,Model Argus PB-1000 (2002), 11 descendants of its own
- K053207: Argus, Model LCM (2006), 5 descendants of its own
- K101619: Welch Allyn 1500 Patient Monitor (2010), 4 descendants of its own
- K133973: Tempus Pro with Enhanced Features (2014), 3 descendants of its own
- K170567: Tempus Pro Patient Monitor (2017), 2 descendants of its own

## Indications for use
The Cardiovit CS-200 device maybe used to record and store standard 12 lead Electrocardiograms (ECG) at patients resting or exercising. Resting ECG's are automatically measured and interpreted by the optionally available Schiller BCG interpretation program.

Source page: https://510kreport.com/device/K970879
Methodology: https://510kreport.com/methodology