DISPOSABLE BLOOD PRESSURE CUF
Device Facts
| Record ID | K102792 |
|---|---|
| Device Name | DISPOSABLE BLOOD PRESSURE CUF |
| Applicant | Caremate Medical Device Co., Ltd. |
| Product Code | DXQ · Cardiovascular |
| Decision Date | Jan 26, 2011 |
| 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.