# K042827: Cardiofax CE, Model Pea-1110K

- Pathway: 510(k) (Traditional)
- Applicant: Nihon Kohden America, Inc.
- Decided: Jan 6, 2005 after 86 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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-9130K: named in the summary without a submission number

## Indications for use
The Cardiofax CE electrocardiograph is intended for medical purposes to process the electrical signals transmitted through two or more electrocardiograph electrodes to produce a visual display and/or wireless transmission of data to a remote printer and/or computer. For non-interpretive applications, the device is intended for use with a full range of patient populations as determined by a clinician. The devices also provide an interpretive ECG program intended 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 physician in diagnosis. Assessments provided by the interpretation program are not intended as the sole basis for diagnosis, All assessments provided by the interpretation program are recommended for review by qualified physicians trained In electrocardiography.

Source page: https://510kreport.com/device/K042827
Methodology: https://510kreport.com/methodology