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FDA 510(k)

TetraGraph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）

K号: K261098 · 2026-05-22

申请人Senzime AB
决定日期2026-05-22
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 (SEN 2015)Accessories:TetraSens (SEN 2012)TetraSens Pediatric (SEN 2013)TetraSensitive (SEN 2016)TetraHub (SEN 2017) is the device name listed in this FDA 510(k) record. The listed applicant is Senzime AB. It received FDA 510(k) clearance on 2026-05-22 under 510(k) number K261098. 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 (SEN 2015)Accessories:TetraSens (SEN 2012)TetraSens Pediatric (SEN 2013)TetraSensitive (SEN 2016)TetraHub (SEN 2017)?

TetraGraph Neuromuscular Transmission Monitor (SEN 2015)Accessories:TetraSens (SEN 2012)TetraSens Pediatric (SEN 2013)TetraSensitive (SEN 2016)TetraHub (SEN 2017) is a medical device that received FDA 510(k) clearance on 2026-05-22. The listed applicant is Senzime AB. The 510(k) number is K261098.

When did TetraGraph Neuromuscular Transmission Monitor (SEN 2015)Accessories:TetraSens (SEN 2012)TetraSens Pediatric (SEN 2013)TetraSensitive (SEN 2016)TetraHub (SEN 2017) receive FDA 510(k) clearance?

TetraGraph Neuromuscular Transmission Monitor (SEN 2015)Accessories:TetraSens (SEN 2012)TetraSens Pediatric (SEN 2013)TetraSensitive (SEN 2016)TetraHub (SEN 2017) received FDA 510(k) clearance on 2026-05-22, under 510(k) number K261098.

Who is the listed applicant for TetraGraph Neuromuscular Transmission Monitor (SEN 2015)Accessories:TetraSens (SEN 2012)TetraSens Pediatric (SEN 2013)TetraSensitive (SEN 2016)TetraHub (SEN 2017)?

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 (SEN 2015)Accessories:TetraSens (SEN 2012)TetraSens Pediatric (SEN 2013)TetraSensitive (SEN 2016)TetraHub (SEN 2017)?

The FDA product code for TetraGraph Neuromuscular Transmission Monitor (SEN 2015)Accessories:TetraSens (SEN 2012)TetraSens Pediatric (SEN 2013)TetraSensitive (SEN 2016)TetraHub (SEN 2017) 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。

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

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。

K220530Tetragraph神经肌肉传导监测器K190795Tetragraph神经肌肉传导监测器

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。

K250887神经肌肉传导监测器TOF3D (2510091)MIPM Mammendorfer Institut für Physik und Medizin GmbHK243339WiTOFIdmedK242525iTOF®Nerbio Medical Software Platforms, Inc.K220530Tetragraph神经肌肉传导监测器Senzime ABK220976Life 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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