Tetragraph神经肌肉传导监测器
K号: K220530 · 2022-08-17
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申请人Senzime AB
决定日期2022-08-17
产品代码KOI
咨询委员会AN
请注意，由于您没有提供完整的医疗设备监管文本，我无法提供完整的翻译。如果您能提供完整的文本，我将很乐意为您翻译。
决定实质等同
器械摘要
Tetragraph Neuromuscular Transmission Monitor is the device name listed in this FDA 510(k) record. The listed applicant is Senzime AB. It received FDA 510(k) clearance on 2022-08-17 under 510(k) number K220530. The device is classified under product code KOI. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Tetragraph Neuromuscular Transmission Monitor?
Tetragraph Neuromuscular Transmission Monitor is a medical device that received FDA 510(k) clearance on 2022-08-17. The listed applicant is Senzime AB. The 510(k) number is K220530.
When did Tetragraph Neuromuscular Transmission Monitor receive FDA 510(k) clearance?
Tetragraph Neuromuscular Transmission Monitor received FDA 510(k) clearance on 2022-08-17, under 510(k) number K220530.
Who is the listed applicant for Tetragraph Neuromuscular Transmission Monitor?
The FDA 510(k) record lists Senzime AB as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Tetragraph Neuromuscular Transmission Monitor?
The FDA product code for Tetragraph Neuromuscular Transmission Monitor is KOI.
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。
列明Senzime AB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。
相关器械（代码：KOI）
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。
K261098TetraGraph神经肌肉传导监测器（SEN 2015）配件：TetraSens（SEN 2012）TetraSens儿童（SEN 2013）TetraSensitive（SEN 2016）TetraHub（SEN 2017）Senzime ABK250887神经肌肉传导监测器TOF3D (2510091)MIPM Mammendorfer Institut für Physik und Medizin GmbHK243339WiTOFIdmedK242525iTOF®Nerbio Medical Software Platforms, Inc.K220976Life Scope PT BSM-1700系列床旁监护仪Nihon Kohden CorporationK212434神经肌肉传导监测器TOF3DMIPM Mammendorfer Institut für Physik und Medizin GmbH
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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