SPHYGURITE
Device Facts
| Record ID | K821095 |
|---|---|
| Device Name | SPHYGURITE |
| Applicant | Associated Medical Devices, Inc. |
| Product Code | DXQ · Cardiovascular |
| Decision Date | Jun 10, 1982 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.1120 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A blood pressure cuff is a device that has an inflatable bladder in an inelastic sleeve (cuff) with a mechanism for inflating and deflating the bladder. The cuff is used in conjunction with another device to determine a subject's blood pressure.
