FDA 510(k)

四格輔神經肌肉傳導監測器

K 號：K190795 · 2019-10-18

決定日期2019-10-18

產品代碼KOI

諮詢委員會AN

決定相當於

器材摘要

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 2019-10-18 under 510(k) number K190795. 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?

Tetragraph Neuromuscular Transmission Monitor is a medical device that received FDA 510(k) clearance on 2019-10-18. The listed applicant is Senzime AB. The 510(k) number is K190795.

When did Tetragraph Neuromuscular Transmission Monitor receive FDA 510(k) clearance?

Tetragraph Neuromuscular Transmission Monitor received FDA 510(k) clearance on 2019-10-18, under 510(k) number K190795.

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.

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。

K261098TetraGraph 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）K220530四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。

K261098TetraGraph 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）Senzime AB K250887神經肌肉傳導監測器 TOF3D (2510091)MIPM Mammendorfer Institut für Physik und Medizin GmbH K243339WiTOFIdmed K242525iTOF®Nerbio Medical Software Platforms, Inc.K220530四格輔神經肌肉傳導監測器Senzime AB K220976Life Scope PT BSM-1700系列床邊監護儀Nihon Kohden Corporation

官方來源

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