CAMBRIDGE HEART CH 2000 STRESS TEST SYSTEM
Device Facts
| Record ID | K950018 |
|---|---|
| Device Name | CAMBRIDGE HEART CH 2000 STRESS TEST SYSTEM |
| Applicant | Cambridge Heart, Inc. |
| Product Code | DPS · Cardiovascular |
| Decision Date | Feb 29, 1996 |
| 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.