OSCAR 2, MODEL 222
Device Facts
| Record ID | K003004 |
|---|---|
| Device Name | OSCAR 2, MODEL 222 |
| Applicant | Suntech Medical Instruments, Inc. |
| Product Code | DXN · Cardiovascular |
| Decision Date | Oct 25, 2000 |
| Decision | SESE |
| Submission Type | Special |
| 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.
