# K111805: Ecg Series Electrocardiograph

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Instrumentations, Inc.
- Decided: Aug 24, 2011 after 58 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: 5 generations back to K921669 (1993). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091513: Smart Ecg Series Electrocardiograph, Models SE-3, SE-300A and 300B, SE-6, SE-600, SE-12, SE-12 Express and SE-1200, Edan Instruments, Inc. (2009) Summary page 2.
- K014108: Mac 5000 Ecg Analysis System, General Electric Medical Systems Information Techn (2002) Summary page 2.

## Indications for use
The intended use of the EGG Series Electrocardiograph is to acquire EG signals from adult and pediatric patients through the body surface 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 EGG with measurements and interpretative statements is offered to the clinician on an advisory basis only.

Source page: https://510kreport.com/device/K111805
Methodology: https://510kreport.com/methodology