FINOMETER MODEL-2 WITH ACCESSORIES
Device Facts
| Record ID | K063111 |
|---|---|
| Device Name | FINOMETER MODEL-2 WITH ACCESSORIES |
| Applicant | Finapres Medical Systems B.V. |
| Product Code | DXN · Cardiovascular |
| Decision Date | Feb 1, 2007 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.1130 |
| Device Class | Class 2 |
| Attributes | 3rd-Party Reviewed |
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.
