HEWLETT-PACKARD MODELS M1400A, M1402A & M1401A
Device Facts
| Record ID | K911139 |
|---|---|
| Device Name | HEWLETT-PACKARD MODELS M1400A, M1402A & M1401A |
| Applicant | Hewlett-Packard Co. |
| Product Code | DRT · Cardiovascular |
| Decision Date | Jun 11, 1991 |
| 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.
