ARS-EKG 12K INTERPRETIVE ELECTROCARDIOGRAPHY SYST
Device Facts
| Record ID | K914206 |
|---|---|
| Device Name | ARS-EKG 12K INTERPRETIVE ELECTROCARDIOGRAPHY SYST |
| Applicant | Kardiosis Ltd. Co. |
| Product Code | DPS · Cardiovascular |
| Decision Date | Mar 30, 1992 |
| 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.