MODIFICATION TO HP M2376A DEVICE LINK SYSTEM
Device Facts
| Record ID | K000635 |
|---|---|
| Device Name | MODIFICATION TO HP M2376A DEVICE LINK SYSTEM |
| Applicant | Agilent Technologies, Inc. |
| Product Code | MWI · Cardiovascular |
| Decision Date | Mar 20, 2000 |
| Decision | SESE |
| Submission Type | Special |
| 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.
