# K031182: Eli 200+ Audicor

- Pathway: 510(k) (Traditional)
- Applicant: Mortara Instrument, Inc.
- Decided: Jul 25, 2003 after 101 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: 1 generation back to K920626 (1992). 2 ancestors in all.
44 later devices descend from it; 5 cite it directly.
0 of 47 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K920626: Model Eli 200 Electrocardiograph, Mortara Instrument, Inc. (1992) Summary page 1.
- K001349: Cardiovise Ecg Interpretative Software, Inovise Medical, Inc. (2000) Summary page 1.
- (no number) 1514A ECG/Phono System: named in the summary without a submission number

## Most influential descendants
- K031517: Zargis Acoustic Cardioscan (2004), 19 descendants of its own
- K060197: Zargis Acoustic Cardioscan (Zac), Model Zac 6.28 (2006), 15 descendants of its own
- K083309: Zargis Acoustic Cardioscan, Version 9.33 (2009), 14 descendants of its own
- K110704: SENSI (2011), 13 descendants of its own
- K032145: Audicor Upgrade System (2003), 13 descendants of its own

## Indications for use
The ELI 200+ with Audicor is a resting electrocardiograph that provides simultaneous 12-lead ECG acquisition and heart sound data (COR - Correlated Audioelectric Cardiography). The ELI 200+ Audicor Option Electrocardiograph is intended to acquire, record and then store acquired cardiac data of symptomatic patients. The ELI 200+ Audicor Option can also be used to acquire both 12-lead ECG and heart sound data at the same time. The cardiac data is reviewed, confirmed, and used by trained medical personnel in the diagnosis of patients with LVH, Acute and Age Undetermined MI and detection of S3/S4 Heart Sounds. The S3 and S4 Heart Sounds are useful in the identification of cardiac conditions associated with Left Ventricular dysfunction. This device is appropriate for the indications listed below: The device is indicated for use to acquire, analyze, display and print ECG and heart sound (COR) data. The device is indicated for use to provide interpretation of the data for consideration by physicians. The device is indicated for use in a clinical setting, by a physician or by trained personnel who are acting on the orders of a licensed physician. It is not intended as a sole means of diagnosis. The interpretations of ECG and heart sound data (COR) offered by the device are only significant when used in conjunction with physician overread as well as consideration of all other relevant patient data. The device is indicated for use on adult populations, typically symptomatic. The device is not intended to be used as a vital signs physiological monitor. Evaluation of cardiac conditions such as LVH, Acute and Age Undetermined MI and detection of S3 and S4 heart sounds.

Source page: https://510kreport.com/device/K031182
Methodology: https://510kreport.com/methodology