RESTING ECG SOFTWARE FRO G-2000 ELECTROCARDIOGRAPH
Device Facts
| Record ID | K850322 |
|---|---|
| Device Name | RESTING ECG SOFTWARE FRO G-2000 ELECTROCARDIOGRAPH |
| Applicant | Eaton Medical Group |
| Product Code | DPS · Cardiovascular |
| Decision Date | May 16, 1985 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.2340 |
| Device Class | Class 2 |
Regulatory Classification
Identification
An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.