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FDA 510(k)

Checkpoint Guardian 手术室导联，中号，Checkpoint Guardian 手术室导联，大号

K号: K212355 · 2021-08-26

申请人Checkpoint Surgical
决定日期2021-08-26
产品代码ETN
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

Checkpoint Guardian Intraoperative Lead, Medium, Checkpoint Guardian Intraoperative Lead, Large is the device name listed in this FDA 510(k) record. The listed applicant is Checkpoint Surgical. It received FDA 510(k) clearance on 2021-08-26 under 510(k) number K212355. The device is classified under product code ETN. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Checkpoint Guardian Intraoperative Lead, Medium, Checkpoint Guardian Intraoperative Lead, Large?

Checkpoint Guardian Intraoperative Lead, Medium, Checkpoint Guardian Intraoperative Lead, Large is a medical device that received FDA 510(k) clearance on 2021-08-26. The listed applicant is Checkpoint Surgical. The 510(k) number is K212355.

When did Checkpoint Guardian Intraoperative Lead, Medium, Checkpoint Guardian Intraoperative Lead, Large receive FDA 510(k) clearance?

Checkpoint Guardian Intraoperative Lead, Medium, Checkpoint Guardian Intraoperative Lead, Large received FDA 510(k) clearance on 2021-08-26, under 510(k) number K212355.

Who is the listed applicant for Checkpoint Guardian Intraoperative Lead, Medium, Checkpoint Guardian Intraoperative Lead, Large?

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

What is the FDA product code for Checkpoint Guardian Intraoperative Lead, Medium, Checkpoint Guardian Intraoperative Lead, Large?

The FDA product code for Checkpoint Guardian Intraoperative Lead, Medium, Checkpoint Guardian Intraoperative Lead, Large is ETN.

相关临床试验

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。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

相关器械（代码：ETN）

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。

K253536Evala神经刺激器（EPNR002）Epineuron Technologies, Inc.K251672NIM Essence® EMG 气管插管 (NIMEID060); NIM Essence® EMG 气管插管 (NIMEID065); NIM Essence® EMG 气管插管 (NIMEID070); NIM Essence® EMG 气管插管 (NIMEID075); NIM Essence® EMG 气管插管 (NIMEID080)Medtronic Xomed, Inc.K242852ALM 管内径 6.0, 外径 8.2 (520843), ALM 管内径 7.0, 外径 9.7 (520845), ALM 管内径 7.5, 外径 10.3 (520846), ALM 管内径 8.0, 外径 11.0 (520847)Inomed Medizintechnik GmbHK233001Bioscope Neuromonitor DeviceBiosys Biyomedikal Muhendislik San. VE Tic. A.S.K241917EARP 神经袖套电极Retropsoas Technologies, LLCK232888一次性喉部电极Suzhou Haishen Medical Device Associates Co., Ltd.

官方来源

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