PHYSIOLOGICAL MONITOR, MODELS 401,402 & 403
Device Facts
| Record ID | K862647 |
|---|---|
| Device Name | PHYSIOLOGICAL MONITOR, MODELS 401,402 & 403 |
| Applicant | Ivy Biomedical Systems, Inc. |
| Product Code | DSK · Cardiovascular |
| Decision Date | Aug 18, 1986 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.1110 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A blood pressure computer is a device that accepts the electrical signal from a blood pressure transducer amplifier and indicates the systolic, diastolic, or mean pressure based on the input signal.