FDA 510(k)

WiScope數位支氣管內鏡系統，WiScope一次性使用數位柔軟支氣管內鏡，WiScope影像系統

K 號：K220399 · 2022-06-16

決定日期2022-06-16

產品代碼EOQ

諮詢委員會中文(台灣): 此醫療設備之規範性文件遵循「醫療規範-v1」政策。以下為該文件之翻譯：此醫療設備已通過美國食品藥品管理局（FDA）的510(k)認證，並獲得PMA許可。該設備的臨床試驗編號為NCTXXXXXXX，並在PubMed上以PMIDXXXXXXX登錄。該設備的識別碼為XXXXXXXX，相關資訊請參考以下網址：[URL]。公司名稱：[公司名稱] 產品名稱：[產品名稱]

決定相當於

器材摘要

WiScope Digital Bronchoscope System, WiScope Single-Use Digital Flexible Bronchoscope, WiScope Image System is the device name listed in this FDA 510(k) record. The listed applicant is OTU Medical, Inc.. It received FDA 510(k) clearance on 2022-06-16 under 510(k) number K220399. The device is classified under product code EOQ. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the WiScope Digital Bronchoscope System, WiScope Single-Use Digital Flexible Bronchoscope, WiScope Image System?

WiScope Digital Bronchoscope System, WiScope Single-Use Digital Flexible Bronchoscope, WiScope Image System is a medical device that received FDA 510(k) clearance on 2022-06-16. The listed applicant is OTU Medical, Inc.. The 510(k) number is K220399.

When did WiScope Digital Bronchoscope System, WiScope Single-Use Digital Flexible Bronchoscope, WiScope Image System receive FDA 510(k) clearance?

WiScope Digital Bronchoscope System, WiScope Single-Use Digital Flexible Bronchoscope, WiScope Image System received FDA 510(k) clearance on 2022-06-16, under 510(k) number K220399.

Who is the listed applicant for WiScope Digital Bronchoscope System, WiScope Single-Use Digital Flexible Bronchoscope, WiScope Image System?

The FDA 510(k) record lists OTU Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for WiScope Digital Bronchoscope System, WiScope Single-Use Digital Flexible Bronchoscope, WiScope Image System?

The FDA product code for WiScope Digital Bronchoscope System, WiScope Single-Use Digital Flexible Bronchoscope, WiScope Image System is EOQ.

其他以 OTU Medical, Inc. 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。

K231702WiScope®數位膀胱鏡系統，WiScope®一次性使用數位柔軟膀胱鏡，WiScope®醫療平板電腦 K212202WiScope數位膀胱鏡系統，WiScope一次性使用數位柔軟膀胱鏡，WiScope影像系統 K210579WiScope OM 経鏡系統，WiScope 單次使用數字柔軟輸尿管鏡。總管鏡，WiScope 圖像系統 K181977WiScope數位內視鏡系統

相關器械（代碼：EOQ）

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。

K261637單次使用柔軟式支氣管內鏡Hunan Vathin Medical Instrument Co., Ltd.K260309Ambu® aScope™ 5 銀喉鏡 2.7/1.2；Ambu® aScope™ 5 銀喉鏡 4.2/2.2；Ambu® aScope™ 5 銀喉鏡 4.2/2.2 樣本組Ambu A/S K2540263.8mm 瘦版 ProVu 電子內視鏡 (090-02-0038U)；5.0mm 标準 ProVu 電子內視鏡 (090-02-0050U)；6.0mm 大型 ProVu 電子內視鏡 (090-02-0060U)；ProVu 電子內視鏡 8 識別器 (040-07-0082U)Flexicare Medical Limited.K260382MONARCH™ 平台（MON-000008）Auris Health, Inc.K254037肺流氣道導管Free Flow Medical, Inc.K253137富士通內視鏡型號 EB-840S；富士通內視鏡型號 EB-840TFujifilm Corporation

官方來源

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