FUKUDA DENSHI MODEL FX-1201
Device Facts
| Record ID | K884992 |
|---|---|
| Device Name | FUKUDA DENSHI MODEL FX-1201 |
| Applicant | Fukuda Denshi USA, Inc. |
| Product Code | DPS · Cardiovascular |
| Decision Date | Jan 12, 1989 |
| 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.