FDA 510(k)

Rescue 肺部抓握镊子

K号: K202987 · 2021-04-29

决定日期2021-04-29

产品代码EOQ

咨询委员会医疗设备监管文本描述翻译如下：关于[公司/产品名称]的监管信息： - 美国食品药品监督管理局（FDA）批准号：[510(k)编号] - 预市场批准（PMA）申请号：[PMA编号] - 临床试验注册号（NCT）：[NCT编号] - 医学文献标识符（PMID）：[PMID编号] - 产品标识符：[标识符] - 相关政策：医疗监管政策v1 - 更多信息请访问：[URL] 请注意，以上翻译保留了公司/产品名称、FDA、510(k)、PMA、NCT、PMID、标识符和URL。

决定实质等同

器械摘要

Rescue Pulmonary Grasping Forceps is the device name listed in this FDA 510(k) record. The listed applicant is Anrei Medical (Hangzhou) Co., Ltd.. It received FDA 510(k) clearance on 2021-04-29 under 510(k) number K202987. The device is classified under product code EOQ. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Rescue Pulmonary Grasping Forceps?

Rescue Pulmonary Grasping Forceps is a medical device that received FDA 510(k) clearance on 2021-04-29. The listed applicant is Anrei Medical (Hangzhou) Co., Ltd.. The 510(k) number is K202987.

When did Rescue Pulmonary Grasping Forceps receive FDA 510(k) clearance?

Rescue Pulmonary Grasping Forceps received FDA 510(k) clearance on 2021-04-29, under 510(k) number K202987.

Who is the listed applicant for Rescue Pulmonary Grasping Forceps?

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

What is the FDA product code for Rescue Pulmonary Grasping Forceps?

The FDA product code for Rescue Pulmonary Grasping Forceps is EOQ.

列明Anrei Medical (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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相关器械（代码：EOQ）

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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