# K112135: Ecg-6 Series Electrocardiograph

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Instrumentations, Inc.
- Decided: Aug 5, 2011 after 10 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: 3 generations back to K984504 (1999). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090367: SE-601 Series Electrocardiograph, Edan Instruments, Inc. (2009) Summary page 2.

## Indications for use
The intended use of the ECG-6 Series 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 EGG 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/K112135
Methodology: https://510kreport.com/methodology