OED · Antimicrobial Blood Pressure Cuff
Cardiovascular · 21 CFR 870.1120 · Class 2
Overview
| Product Code | OED |
|---|---|
| Device Name | Antimicrobial Blood Pressure Cuff |
| Regulation | 21 CFR 870.1120 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
| 3rd-Party Reviewable | Yes |
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.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K122365 | ULTRACHECK CURVE BLOOD PRESSURE CUFFS | Statcorp Medical | Jun 4, 2013 | SESE |
| K071885 | ANTIMICROBIAL AND SINGLE-PATIENT CUFFS | Philips Medical Systems | Dec 20, 2007 | SESE |
Top Applicants
- Philips Medical Systems — 1 clearance
- Statcorp Medical — 1 clearance
