OMRON DIGITAL BP MONITOR HEM-400C
Device Facts
| Record ID | K851707 |
|---|---|
| Device Name | OMRON DIGITAL BP MONITOR HEM-400C |
| Applicant | Omron Tateisi Electronics Co. |
| Product Code | DXN · Cardiovascular |
| Decision Date | Jul 31, 1985 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.1130 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.
