# K093339: Eli PC Electrocardiograph

- Pathway: 510(k) (Abbreviated)
- Applicant: Mortara Instrument, Inc.
- Decided: Feb 19, 2010 after 116 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: 3 generations back to K933143 (1994). 4 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082946: Mortara Eli 350 Electrocardiograph, Mortara Instrument, Inc. (2008) Summary page 1.
- K955023: Brentwood PC-Ecg, Brentwood Medical Products, Inc. (1997) Summary page 1.

## Most influential descendants
- K120865: Rscribe Electrocardiograph (2012), 2 descendants of its own
- K110065: Spaulding IQ Electrocardiograph (2011), 2 descendants of its own
- K150564: Spaulding Electrocardiograph 2100iQ (2015), 1 descendant of its own
- K260250: QCA 10 Electrocardiograph (QCARD-10); QCA 10W Electrocardiograph (QCARD-10W) (2026), 0 descendants of its own
- K163607: ECG Acquisition Systems (2017), 0 descendants of its own

## Recalls of this device
- Mar 18, 2020 · Class II · Z-1811-2020: Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25 Medical Electrical Equipment.

## Indications for use
The ELI PC Electrocardiograph is a non-invasive prescription device * The proposed Mortara ELI-PC Electrocardiograph is indicated for use to acquire, analyze, display and print electrocardiograms. * The device is indicated for use for patients of any age, diseased or non-diseased. * The device is indicated for use to provide interpretation of the data for consideration by a physician. * The interpretations of ECG offered by the device are only significant when used in conjunction with a physician over-read as well as consideration of all other relevant patient data. * The device is indicated for use in a clinical setting, by qualified medical professionals, properly trained for ECG monitoring and use of the system. The personnel must be experienced in cardiovascular problematic situations and emergency procedures or pathologies related to cardiac involvements. It is not intended as a sole means of diagnosis. * The device is not intended to be used as a vital signs physiological monitor. * It is not designed for out of hospital transport. * It is not designed for use in highly invasive environments, such as an operating theatre. * The cardiac data and analysis provided is reviewed, confirmed, and used by trained medical personnel in the diagnosis of patients with various rhythm patterns.

Source page: https://510kreport.com/device/K093339
Methodology: https://510kreport.com/methodology