MODELS WEP-8410A AND WEP-8420A TELEMETRY CENTRAL
Device Facts
| Record ID | K901034 |
|---|---|
| Device Name | MODELS WEP-8410A AND WEP-8420A TELEMETRY CENTRAL |
| Applicant | Nihon Kohden America, Inc. |
| Product Code | DRT · Cardiovascular |
| Decision Date | Apr 19, 1990 |
| 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.
