C/PES 9201, ECG STRESS TESTING SYS
Device Facts
| Record ID | K850114 |
|---|---|
| Device Name | C/PES 9201, ECG STRESS TESTING SYS |
| Applicant | Gould, Inc. |
| Product Code | DRT · Cardiovascular |
| Decision Date | Feb 22, 1985 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.2300 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.
