# K961272: Nihon Kohden Ecg-9320A Cardiofax and Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Nihon Kohden America, Inc.
- Decided: Nov 1, 1996 after 213 days
- Product code: LOS
- 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 K865032 (1987). 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)
- K865032: Cardiofax-V Ecg-834OA, Nihon Kohden America, Inc. (1987) Summary page 1.
- K895520: Pagewriter Xli M1700A & Pagewriter XL M1701A, Hewlett-Packard Co. (1990) Summary page 1.

## Indications for use
Nihon Kohden's Cardiofax, model number ECG-9320A, is intended for medical purposes used to process the electrical signals transmitted through two or more electrocardiograph electrodes and to produce a visual display and prepare a record of the electrical signals produced by the heart. This product will be available for use by a physician within the hospital, laboratory, clinic or in a remote environment under the direct supervision of a physician.

Source page: https://510kreport.com/device/K961272
Methodology: https://510kreport.com/methodology