# K183369: COR12 Ecg

- Pathway: 510(k) (Traditional)
- Applicant: Corscience GmbH & Co.
- Decided: Dec 28, 2018 after 24 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: 6 generations back to K002074 (2000). 21 ancestors in all.
No later device cites it as a predicate yet.
1 of 22 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150810: Vyntus / SentrySuite Product Line, Carefusion Germany 234 GmbH (2015) Summary page 4.

## Indications for use
The COR12 ECG is intended for measuring the surface electrocardiogram (ECG) of a patient. The acquired ECG can be recorded and displayed on a screen or printed on paper. The COR12 ECG can be used for applications in patients age 4 years and older and a weight of 20 kg or higher. The COR12 ECG is intended to be used for routine ECG collection, recording both under resting and stress conditions. The measurement is performed by trained healthcare professionals under the direction of a physician in healthcare facilities (e.g. the doctor’s office or hospital).

Source page: https://510kreport.com/device/K183369
Methodology: https://510kreport.com/methodology