FDA 510(k)

智能電纜NMT模組及配件，Life Scope BSM 3000系列及Life Scope BSM 6000系列

K 號：K201949 · 2021-05-02

決定日期2021-05-02

產品代碼KOI

諮詢委員會AN

決定相當於

器材摘要

Smart Cable NMT Module and Accessories, Life Scope BSM 3000 Series and Life Scope BSM 6000 Series is the device name listed in this FDA 510(k) record. The listed applicant is Nihon Kohden Corporation. It received FDA 510(k) clearance on 2021-05-02 under 510(k) number K201949. 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 Smart Cable NMT Module and Accessories, Life Scope BSM 3000 Series and Life Scope BSM 6000 Series?

Smart Cable NMT Module and Accessories, Life Scope BSM 3000 Series and Life Scope BSM 6000 Series is a medical device that received FDA 510(k) clearance on 2021-05-02. The listed applicant is Nihon Kohden Corporation. The 510(k) number is K201949.

When did Smart Cable NMT Module and Accessories, Life Scope BSM 3000 Series and Life Scope BSM 6000 Series receive FDA 510(k) clearance?

Smart Cable NMT Module and Accessories, Life Scope BSM 3000 Series and Life Scope BSM 6000 Series received FDA 510(k) clearance on 2021-05-02, under 510(k) number K201949.

Who is the listed applicant for Smart Cable NMT Module and Accessories, Life Scope BSM 3000 Series and Life Scope BSM 6000 Series?

FDA 510(k) 記錄中將 Nihon Kohden Corporation 列為申請人。這並不單獨確立設備製造商的身份。

What is the FDA product code for Smart Cable NMT Module and Accessories, Life Scope BSM 3000 Series and Life Scope BSM 6000 Series?

The FDA product code for Smart Cable NMT Module and Accessories, Life Scope BSM 3000 Series and Life Scope BSM 6000 Series is KOI.

其他以 Nihon Kohden Corporation 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。

K251641GF-310R 多氣體單元（GF-310R）K260747YP-710T系列無創血壓袖帶；YP-840T系列一次性袖帶 K251366EEG-1260A 神經纖維系統（EEG-1260A）；JE-940A 腦電放大器單元（JE-940A）；LS-940A 光刺激器（LS-940A）K243956TG-980P 二氧化碳感測器套件（TG-980P）；TG-980P1 二氧化碳感測器套件（TG-980P1）K223567CNS-2101 中樞監控器 K220976Life Scope PT BSM-1700系列床邊監護儀

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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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