# K090367: SE-601 Series Electrocardiograph

- Pathway: 510(k) (Traditional)
- Applicant: Edan Instruments, Inc.
- Decided: Jun 3, 2009 after 110 days
- Product code: DPS (Electrocardiograph)
- Device class: 2
- Regulation: 21 CFR 870.2340
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K984504 (1999). 3 ancestors in all.
13 later devices descend from it; 3 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072217: Ecg-1250A Series Cardiofax S and Ecg-1350A Series Cardiofax M, Nihon Kohden America, Inc. (2007) Summary page 1.

## Most influential descendants
- 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
- K171942: Electrocardiograph (2018), 3 descendants of its own
- K170995: Electrocardiograph (2017), 3 descendants of its own

## Recalls of this device
- Sep 10, 2010 · Not classified · Z-0743-2012: CardioExpress SL6 ECG cable provided with the electrocardiograph is mislabeled. The left arm (LA) is mislabeled as right leg (RL). The left leg (LL) is mislabeled as left arm (LA). The right leg (RL) 

## Indications for use
The intended use of electrocardiograph is to acquire ECG signals from adult and pediatric patients through body surface with ECG electrodes. The electrocardiograph is only intended to be used in hospitals or healthcare facilities by doctors and trained healthcare professionals. The cardiogram recorded by the electrocardiograph can help users to analyze and diagnose heart disease. However, the interpreted ECG with measurements and interpretive statements is only intended to be used on adult patients and is offered to clinicians on an advisory basis only.

Source page: https://510kreport.com/device/K090367
Methodology: https://510kreport.com/methodology