OKV

Obstetrical Kit

产品代码

OKV

器械名称

Obstetrical Kit

管理类别

第 2 类（Class II）

21 CFR 条款

21 CFR 884.4520

FDA 专业组

Obstetrics/Gynecology

上市路径

Enforcement Discretion

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）。