THE HOLTER REPORTER (TM)
Device Facts
| Record ID | K860249 |
|---|---|
| Device Name | THE HOLTER REPORTER (TM) |
| Applicant | Applied Cardiac Systems |
| Product Code | DPS · Cardiovascular |
| Decision Date | Mar 11, 1986 |
| 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.