# K865032: Cardiofax-V Ecg-834OA

- Pathway: 510(k) (Traditional)
- Applicant: Nihon Kohden America, Inc.
- Decided: Mar 10, 1987 after 77 days
- Product code: DSI (Detector And Alarm, Arrhythmia)
- Device class: 2
- Regulation: 21 CFR 870.1025
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

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

## Most influential descendants
- K972310: Nihon Kohden QP-932E Ecg Exercise Test Option for the Nihon Kohden Ecg-9320/a Cardiofax Electrocardiograph (1997), 1 descendant of its own
- K072060: QP-156E Ecg Exercise Test Option for the Ecg-1500A Series/Cardiofax V (2007), 0 descendants of its own
- K961272: Nihon Kohden Ecg-9320A Cardiofax and Accessories (1996), 0 descendants of its own

Source page: https://510kreport.com/device/K865032
Methodology: https://510kreport.com/methodology