OED

Antimicrobial Blood Pressure Cuff

Product code

OED

Device name

Antimicrobial Blood Pressure Cuff

Device class

Class 2

21 CFR

21 CFR 870.1120

Medical specialty

Cardiovascular

Marketing pathway

510(K)

Flag

Third-party review eligible

510(k) clearances (all years, FDA)

2 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).