FDA 510(k)

RADIFOCUS 扭矩装置

K号: K220934 · 2022-06-29

申请人Terumo Medical Products (Hangzhou) Co., Ltd.

决定日期2022-06-29

产品代码MOF

咨询委员会CV 请注意，由于原文未提供具体内容，以下是一个示例翻译： --- 产品名称：[产品名称] 公司名称：[公司名称] FDA批准号：[FDA批准号] 510(k)申请号：[510(k)申请号] PMA申请号：[PMA申请号] 临床试验注册号：[NCT] PubMed ID：[PMID] 产品标识符：[标识符] 产品URL：[URL] --- 请将上述示例中的[产品名称]、[公司名称]、[FDA批准号]等占位符替换为实际内容。

决定实质等同

器械摘要

RADIFOCUS Torque Device is the device name listed in this FDA 510(k) record. The listed applicant is Terumo Medical Products (Hangzhou) Co., Ltd.. It received FDA 510(k) clearance on 2022-06-29 under 510(k) number K220934. The device is classified under product code MOF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the RADIFOCUS Torque Device?

RADIFOCUS Torque Device is a medical device that received FDA 510(k) clearance on 2022-06-29. The listed applicant is Terumo Medical Products (Hangzhou) Co., Ltd.. The 510(k) number is K220934.

When did RADIFOCUS Torque Device receive FDA 510(k) clearance?

RADIFOCUS Torque Device received FDA 510(k) clearance on 2022-06-29, under 510(k) number K220934.

Who is the listed applicant for RADIFOCUS Torque Device?

The FDA 510(k) record lists Terumo Medical Products (Hangzhou) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RADIFOCUS Torque Device?

The FDA product code for RADIFOCUS Torque Device is MOF.

列明Terumo Medical Products (Hangzhou) Co., Ltd.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。

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