OED
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Antimicrobial Blood Pressure Cuff
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1120
- Medical specialty
- Cardiovascular
- Flags
- Third-party review eligible
- FDA definition
- Device is a replacement cuff to be used in conjunction with a non-invasive blood pressure monitor. Together the devices determine blood pressures and heart rate. This particular cuff contains an embedded antimicrobial. A blood pressure cuff is a device that has an inflatable bladder in an elastic sleeve(cuff) with a mechanism for inflating the bladder. The cuff is used to determine a subject's blood pressure.
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| Record | Firm | Date | Builder |
|---|---|---|---|
| ULTRACHECK CURVE BLOOD PRESSURE CUFFS (K122365) | Statcorp Medical | 2013-06-04 | + Add |
| ANTIMICROBIAL AND SINGLE-PATIENT CUFFS (K071885) | Philips Medical Systems | 2007-12-20 | + Add |
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