# K183425: Cardiovit at-102 G2

- Pathway: 510(k) (Traditional)
- Applicant: Schiller AG
- Decided: Mar 2, 2020 after 447 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Recalls of this device
- Jul 24, 2024 · Class II · Z-2734-2024: Potential for high-frequency signal artifacts is recorded during an ECG acquisition performed by CARDIOVIT AT-180 electrocardiographs.

## Indications for use
The CARDIOVIT AT-102 G2 is a 12-channel ECG unit used for the recording, analysis, viewing, storage and transmission of ECG waveforms. The CARDIOVIT AT-102 G2 is designed for indoor use and can be used for all patient populations. The CARDIOVIT AT-102 G2 is used to diagnose cardiac abnormalities, and detect acute myocardial ischemia and infarctions in chest pain patients. The CARDIOVIT AT-102 G2 is intended for use in hospitals, cardiology units, outpatient clinical units and general physician's offices.

Source page: https://510kreport.com/device/K183425
Methodology: https://510kreport.com/methodology