FDA 510(k)

NewPrim 系统

K号: K191966 · 2020-02-13

决定日期2020-02-13

产品代码KWH

咨询委员会OR 请注意，由于原文中未提供具体的医疗设备监管文本，以下是一个示例翻译，您可以根据实际文本进行调整： --- 产品名称：[产品名称] 公司名称：[公司名称] 根据FDA 510(k)预市场批准程序，[产品名称]已获得批准，用于[产品用途描述]。产品注册号：[注册号] PMA编号：[PMA编号] 临床试验编号（NCT）：[NCT编号] PubMed ID（PMID）：[PMID编号] 更多信息请访问以下链接： [URL] --- 请将上述示例中的[产品名称]、[公司名称]、[注册号]、[PMA编号]、[NCT编号]、[PMID编号]和[URL]替换为实际的文本内容。

决定实质等同

器械摘要

NewPrim System is the device name listed in this FDA 510(k) record. The listed applicant is Brm Extremities. It received FDA 510(k) clearance on 2020-02-13 under 510(k) number K191966. The device is classified under product code KWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the NewPrim System?

NewPrim System is a medical device that received FDA 510(k) clearance on 2020-02-13. The listed applicant is Brm Extremities. The 510(k) number is K191966.

When did NewPrim System receive FDA 510(k) clearance?

NewPrim System received FDA 510(k) clearance on 2020-02-13, under 510(k) number K191966.

Who is the listed applicant for NewPrim System?

The FDA 510(k) record lists Brm Extremities as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NewPrim System?

The FDA product code for NewPrim System is KWH.

列明Brm Extremities为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K222820BRM 工具螺丝，BIOPLAN 跟骨植入物

官方来源

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