# K942685: Ecg Review Station

- Pathway: 510(k) (Traditional)
- Applicant: Mortara Instrument, Inc.
- Decided: Aug 12, 1997 after 1,162 days
- Product code: DXJ (Display, Cathode-Ray Tube, Medical)
- Device class: 2
- Regulation: 21 CFR 870.2450
- 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 K895232 (1989). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K895232: Model Eli-100/ST Electrocardiograph, Mortara Instrument, Inc. (1989) Summary page 1.
- K922927: Mortara Instrument ST Central Station, Mortara Instrument, Inc. (1992) Summary page 2.

## Indications for use
The ST Review Station is intended to allow Physicians and/or Clinical personnel from ER. Cath Lab, ICU, and other related settings to retiospectively review/analyze stored ECG data. By bcing able review/analyze ECG trends, including ST segment measurements, Clinicians and/or Physicians have access to information 10 assist in their ability to detect changes in a paticnts physiological condition and therefore enabling them to respond accordingly to a paticnts medical needs.

Source page: https://510kreport.com/device/K942685
Methodology: https://510kreport.com/methodology