OED

Antimicrobial Blood Pressure Cuff

产品代码

OED

器械名称

Antimicrobial Blood Pressure Cuff

管理类别

第 2 类（Class II）

21 CFR 条款

21 CFR 870.1120

FDA 专业组

Cardiovascular

上市路径

需提交 510(k) 上市前通告

标记

可走第三方审查

FDA 历史累计 510(k)

2 件（全部年份；本站只收录近三年的明细）

FDA 分类定义

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.

定义原文来自 FDA 器械分类库，属美国联邦政府作品（公有领域）。