# K082946: Mortara Eli 350 Electrocardiograph

- Pathway: 510(k) (Traditional)
- Applicant: Mortara Instrument, Inc.
- Decided: Dec 29, 2008 after 88 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: 2 generations back to K933143 (1994). 2 ancestors in all.
25 later devices descend from it; 7 cite it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062677: Eli 350 Electrocardiograph, Mortara Instrument, Inc. (2006) Summary page 1.

## Most influential descendants
- K131929: Surveyor Central Station (2013), 6 descendants of its own
- K093339: Eli PC Electrocardiograph (2010), 6 descendants of its own
- K142105: Eli 380 Electrocardiograph (2014), 4 descendants of its own
- K173830: MAC VU360 Resting ECG Analysis System (2018), 3 descendants of its own
- K133973: Tempus Pro with Enhanced Features (2014), 3 descendants of its own

## Indications for use
The device is indicated for use to acquire, analyze, display and print electrocardiograms. The device is indicated for use to provide interpretation of the data for consideration by a physician. 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 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 on adult and pediatric populations. The device is not intended to be used as a vital signs physiological monitor.

Source page: https://510kreport.com/device/K082946
Methodology: https://510kreport.com/methodology