FDA 510(k)

NIM PAK 针头; NIM XPAK 针头; NIM 椎弓根探测针

K号: K180542 · 2018-08-22

决定日期2018-08-22

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

NIM PAK Needle; NIM XPAK Needle; NIM Pedicle Probe 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 2018-08-22 under 510(k) number K180542. 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 NIM PAK Needle; NIM XPAK Needle; NIM Pedicle Probe?

NIM PAK Needle; NIM XPAK Needle; NIM Pedicle Probe is a medical device that received FDA 510(k) clearance on 2018-08-22. The listed applicant is Boston Endo Surgical Tech,. The 510(k) number is K180542.

When did NIM PAK Needle; NIM XPAK Needle; NIM Pedicle Probe receive FDA 510(k) clearance?

NIM PAK Needle; NIM XPAK Needle; NIM Pedicle Probe received FDA 510(k) clearance on 2018-08-22, under 510(k) number K180542.

Who is the listed applicant for NIM PAK Needle; NIM XPAK Needle; NIM Pedicle Probe?

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 NIM PAK Needle; NIM XPAK Needle; NIM Pedicle Probe?

The FDA product code for NIM PAK Needle; NIM XPAK Needle; NIM Pedicle Probe 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。

K182662NAV PAK 注射针，NIM NAV PAK 注射针

官方来源

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