FDA 510(k)

NAV PAK 注射针，NIM NAV PAK 注射针

K号: K182662 · 2019-04-10

决定日期2019-04-10

产品代码PDQ

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

NAV PAK Needle, NIM NAV PAK Needle is the device name listed in this FDA 510(k) record. The listed applicant is Boston Endo Surgical Tech,. It received FDA 510(k) clearance on 2019-04-10 under 510(k) number K182662. The device is classified under product code PDQ. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the NAV PAK Needle, NIM NAV PAK Needle?

NAV PAK Needle, NIM NAV PAK Needle is a medical device that received FDA 510(k) clearance on 2019-04-10. The listed applicant is Boston Endo Surgical Tech,. The 510(k) number is K182662.

When did NAV PAK Needle, NIM NAV PAK Needle receive FDA 510(k) clearance?

NAV PAK Needle, NIM NAV PAK Needle received FDA 510(k) clearance on 2019-04-10, under 510(k) number K182662.

Who is the listed applicant for NAV PAK Needle, NIM NAV PAK Needle?

The FDA 510(k) record lists Boston Endo Surgical Tech, as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NAV PAK Needle, NIM NAV PAK Needle?

The FDA product code for NAV PAK Needle, NIM NAV PAK Needle is PDQ.

列明Boston Endo Surgical Tech,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。

K180542NIM PAK 针头; NIM XPAK 针头; NIM 椎弓根探测针

官方来源

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