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FDA 510(k)

Life Scope PT BSM-1700系列，AY系列，資料取得單元，LIFE SCOPE BSM 6000系列床邊監護系統，Nihon Kohden CSM-1901床邊監護系統

K 號：K213316 · 2021-12-29

申請人Nihon Kohden Corporation
決定日期2021-12-29
產品代碼KOI
諮詢委員會AN
決定相當於

器材摘要

Life Scope PT BSM-1700 Series, AY Series, Data Acquisition Unit, LIFE SCOPE BSM 6000 SERIES BEDSIDE MONITORING SYSTEM, Nihon Kohden CSM-1901 BEDSIDE MONITORING SYSTEM 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 2021-12-29 under 510(k) number K213316. 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 Life Scope PT BSM-1700 Series, AY Series, Data Acquisition Unit, LIFE SCOPE BSM 6000 SERIES BEDSIDE MONITORING SYSTEM, Nihon Kohden CSM-1901 BEDSIDE MONITORING SYSTEM?

Life Scope PT BSM-1700 Series, AY Series, Data Acquisition Unit, LIFE SCOPE BSM 6000 SERIES BEDSIDE MONITORING SYSTEM, Nihon Kohden CSM-1901 BEDSIDE MONITORING SYSTEM is a medical device that received FDA 510(k) clearance on 2021-12-29. The listed applicant is Nihon Kohden Corporation. The 510(k) number is K213316.

When did Life Scope PT BSM-1700 Series, AY Series, Data Acquisition Unit, LIFE SCOPE BSM 6000 SERIES BEDSIDE MONITORING SYSTEM, Nihon Kohden CSM-1901 BEDSIDE MONITORING SYSTEM receive FDA 510(k) clearance?

Life Scope PT BSM-1700 Series, AY Series, Data Acquisition Unit, LIFE SCOPE BSM 6000 SERIES BEDSIDE MONITORING SYSTEM, Nihon Kohden CSM-1901 BEDSIDE MONITORING SYSTEM received FDA 510(k) clearance on 2021-12-29, under 510(k) number K213316.

Who is the listed applicant for Life Scope PT BSM-1700 Series, AY Series, Data Acquisition Unit, LIFE SCOPE BSM 6000 SERIES BEDSIDE MONITORING SYSTEM, Nihon Kohden CSM-1901 BEDSIDE MONITORING SYSTEM?

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 Life Scope PT BSM-1700 Series, AY Series, Data Acquisition Unit, LIFE SCOPE BSM 6000 SERIES BEDSIDE MONITORING SYSTEM, Nihon Kohden CSM-1901 BEDSIDE MONITORING SYSTEM?

The FDA product code for Life Scope PT BSM-1700 Series, AY Series, Data Acquisition Unit, LIFE SCOPE BSM 6000 SERIES BEDSIDE MONITORING SYSTEM, Nihon Kohden CSM-1901 BEDSIDE MONITORING SYSTEM is KOI.

相關臨床試驗

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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。

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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 ABK250887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 Corporation

官方來源

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