# K072060: QP-156E Ecg Exercise Test Option for the Ecg-1500A Series/Cardiofax V

- Pathway: 510(k) (Special)
- Applicant: Nihon Kohden America, Inc.
- Decided: Aug 17, 2007 after 21 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: 2 generations back to K865032 (1987). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972310: Nihon Kohden QP-932E Ecg Exercise Test Option for the Nihon Kohden Ecg-9320/a Cardiofax Electrocardiograph, Nihon Kohden America, Inc. (1997) Summary page 1.

## Indications for use
The QP-156E Exercise Test Option with its parent device, the Nihon Kohden ECG-1500A Series/Cardiofax V Electrocardiograph, is intended for medical purposes used to process the electrical signals transmitted through two or more electrocardiograph electrodes to produce a visual display and to prepare a record of the electrical signals produced by the heart. The QP-156E will develop a report based upon acquired data and subsequent calculations. The ECG-1500A Series/Cardiofax V Electrocardiograph with QP-156E Exercise Test Option will be available for use by a physician within a hospital, laboratory, clinic or in a remote environment under the supervision of a physician.

Source page: https://510kreport.com/device/K072060
Methodology: https://510kreport.com/methodology