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FDA 510(k)

TetraGraph 神經肌肉傳導監測器（SEN 2015） 配件：TetraSens（SEN 2012）TetraSens 優幼版（SEN 2013）TetraSensitive（SEN 2016）TetraHub（SEN 2017）

K 號：K261098 · 2026-05-22

申請人Senzime AB
決定日期2026-05-22
產品代碼KOI
諮詢委員會AN
決定相當於

器材摘要

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.

常見問題

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.

相關臨床試驗

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

其他以 Senzime AB 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K220530四格輔神經肌肉傳導監測器K190795四格輔神經肌肉傳導監測器

相關器械（代碼：KOI）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K250887神經肌肉傳導監測器 TOF3D (2510091)MIPM Mammendorfer Institut für Physik und Medizin GmbHK243339WiTOFIdmedK242525iTOF®Nerbio Medical Software Platforms, Inc.K220530四格輔神經肌肉傳導監測器Senzime ABK220976Life Scope PT BSM-1700系列床邊監護儀Nihon Kohden CorporationK212434神經肌肉傳導監測器 TOF3DMIPM Mammendorfer Institut für Physik und Medizin GmbH

官方來源

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