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FDA 510(k)

ALM 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)

K号: K242852 · 2025-06-13

申请人Inomed Medizintechnik GmbH
决定日期2025-06-13
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

ALM Tube I.D. 6.0, O.D. 8.2 (520843), ALM Tube I.D. 7.0, O.D. 9.7 (520845), ALM Tube I.D. 7.5, O.D. 10.3 (520846), ALM Tube I.D. 8.0, O.D. 11.0 (520847) is the device name listed in this FDA 510(k) record. The listed applicant is Inomed Medizintechnik GmbH. It received FDA 510(k) clearance on 2025-06-13 under 510(k) number K242852. 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 ALM Tube I.D. 6.0, O.D. 8.2 (520843), ALM Tube I.D. 7.0, O.D. 9.7 (520845), ALM Tube I.D. 7.5, O.D. 10.3 (520846), ALM Tube I.D. 8.0, O.D. 11.0 (520847)?

ALM Tube I.D. 6.0, O.D. 8.2 (520843), ALM Tube I.D. 7.0, O.D. 9.7 (520845), ALM Tube I.D. 7.5, O.D. 10.3 (520846), ALM Tube I.D. 8.0, O.D. 11.0 (520847) is a medical device that received FDA 510(k) clearance on 2025-06-13. The listed applicant is Inomed Medizintechnik GmbH. The 510(k) number is K242852.

When did ALM Tube I.D. 6.0, O.D. 8.2 (520843), ALM Tube I.D. 7.0, O.D. 9.7 (520845), ALM Tube I.D. 7.5, O.D. 10.3 (520846), ALM Tube I.D. 8.0, O.D. 11.0 (520847) receive FDA 510(k) clearance?

ALM Tube I.D. 6.0, O.D. 8.2 (520843), ALM Tube I.D. 7.0, O.D. 9.7 (520845), ALM Tube I.D. 7.5, O.D. 10.3 (520846), ALM Tube I.D. 8.0, O.D. 11.0 (520847) received FDA 510(k) clearance on 2025-06-13, under 510(k) number K242852.

Who is the listed applicant for ALM Tube I.D. 6.0, O.D. 8.2 (520843), ALM Tube I.D. 7.0, O.D. 9.7 (520845), ALM Tube I.D. 7.5, O.D. 10.3 (520846), ALM Tube I.D. 8.0, O.D. 11.0 (520847)?

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

What is the FDA product code for ALM Tube I.D. 6.0, O.D. 8.2 (520843), ALM Tube I.D. 7.0, O.D. 9.7 (520845), ALM Tube I.D. 7.5, O.D. 10.3 (520846), ALM Tube I.D. 8.0, O.D. 11.0 (520847)?

The FDA product code for ALM Tube I.D. 6.0, O.D. 8.2 (520843), ALM Tube I.D. 7.0, O.D. 9.7 (520845), ALM Tube I.D. 7.5, O.D. 10.3 (520846), ALM Tube I.D. 8.0, O.D. 11.0 (520847) is ETN.

列明Inomed Medizintechnik GmbH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。

K263010ISIS 头箱，ISIS 神经刺激器，ISIS Xpert Plus，ISIS Xpert，ISIS XpressK233292ISIS 头箱，ISIS 神经刺激器，ISIS Xpert Plus，ISIS Xpert，ISIS XpressK223254C2 XploreK212164Mapping Suction ProbeK212166ISIS 头箱，ISIS 神经刺激器，ISIS Xpert Plus，ISIS Xpert，ISIS XpressK152505C2 神经监测系统

查看所有 7 个设备 →

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.K233001Bioscope 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.K230320NIM 标准加强型 EMG 气管插管; CONTACT 加强型 EMG 气管插管Medtronic Xomed, Inc.

官方来源

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。

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