Antimicrobial Blood Pressure Cuff

FDA product code OED · Class II (moderate risk) · 21 CFR 870.1120 · Cardiovascular

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.

2510(k) clearances
0PMA approvals
0recalls

Manufacturers

510(k) clearances

510(k)DeviceApplicantDecision
K122365Ultracheck Curve Blood Pressure CuffsOED · Traditional Statcorp Medical06/04/2013SE
K071885Antimicrobial and Single-Patient CuffsOED · Traditional Philips Medical Systems12/20/2007SE