SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)
Device Facts
| Record ID | K252463 |
|---|---|
| Device Name | SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E) |
| Applicant | Edan Instruments, Inc. |
| Product Code | DPS · Cardiovascular |
| Decision Date | Jul 2, 2026 |
| 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.
