# Antimicrobial Blood Pressure Cuff
> **Product code: OED** · Class II — Moderate Risk (510(k) clearance required) · Cardiovascular · 21 CFR 870.1120
## Classification
- **FDA Product Code:** OED
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 870.1120
- **Review panel:** CV
- **Medical specialty:** Cardiovascular
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** Y
## 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.

## Market data
- **Cleared 510(k) submissions:** 2
- **Registered establishments:** 8
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=OED)
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