# K984504: Nihon Kohden Ecg-9110K and Ecg-9130K Cardiofax Q and Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Nihon Kohden America, Inc.
- Decided: Apr 15, 1999 after 118 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.
17 later devices descend from it; 1 cites it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) ECG-9320A: named in the summary without a submission number

## Most influential descendants
- K072217: Ecg-1250A Series Cardiofax S and Ecg-1350A Series Cardiofax M (2007), 16 descendants of its own
- K090367: SE-601 Series Electrocardiograph (2009), 13 descendants of its own
- K093869: SE-601 Series Electrocardiograph (2010), 10 descendants of its own
- K131503: SE-601 Series Electrocardiograph (2014), 9 descendants of its own
- K160876: PC ECG (2017), 8 descendants of its own

## Indications for use
The ECG-9110K and ECG-9130K Cardiofax Q electrocardiographs are intended for medical purposes to process the electrical signals transmitted through two or more electrocardiograph electrodes to produce a visual display and/or to prepare a record of the electrical signals produced by the heart. For non-interpretive applications, the ECG-9110K and ECG-9130K are intended for use with a full range of patient populations as determined by a clinician. The devices also provide an mterpretlve ECG program mtended for use with patients age 3 years to adult. The interpretation program is intended to provide an assessment of ECG waveform rhythm and morphology to assist the physicidn in diagnosis. Assessments provided by the interpretation program are not intended as the solg basis for diagnosis. All assessments provided by the interpretation program are recommended Tor review by qualified physicians trained in electrocardiography.

Source page: https://510kreport.com/device/K984504
Methodology: https://510kreport.com/methodology