Antimicrobial Blood Pressure Cuff
The Antimicrobial Blood Pressure Cuff (product code OED) is a cardiovascular device used in conjunction with a non-invasive blood pressure monitor to determine blood pressure and heart rate; it incorporates an embedded antimicrobial agent in the cuff material to reduce the risk of cross-contamination between patients. The inflatable cuff applies external pressure to the limb to enable non-invasive blood pressure measurement. This device is FDA Class 2 under regulation 870.1120 in the Cardiovascular specialty, requires 510(k) clearance, and is eligible for third-party review. It carries no implant or life-sustaining flags.
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Basic Information
- Product Code
- OED
- Device Class
- FDA class 2
- Regulation Number
- 870.1120
- Medical Specialty
- Cardiovascular
- Review Panel
- CV
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 8 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 8 registration numbers. Click on an entry to view related FDA registrations.