OED — Antimicrobial Blood Pressure Cuff Class II

FDA Device Classification

Classification Details

Product Code: OED
Device Class: Class II
Regulation Number: 870.1120
Submission Type
Review Panel: CV
Medical Specialty: Cardiovascular
Implant: No

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.

Recent 510(k) Clearances

K-Number	Applicant	Device Name	Date
K122365	statcorp medical	ULTRACHECK CURVE BLOOD PRESSURE CUFFS	June 4, 2013
K071885	philips medical systems	ANTIMICROBIAL AND SINGLE-PATIENT CUFFS	December 20, 2007