OFE

Central Venous Blood Pressure Kit

产品代码: OFE
器械名称: Central Venous Blood Pressure Kit
管理类别: 第 2 类（Class II）
21 CFR 条款: 21 CFR 870.1140
FDA 专业组: Cardiovascular
上市路径: Enforcement Discretion
标记: 豁免 GMP（质量体系）

FDA 分类定义

This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

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）。

FDA 官方分类页： OFE

分类与上市路径以 FDA 现行公告为准。本页数据来自 openFDA（CC0 公有领域），不构成注册策略建议。