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FDA 510(k)

Logic HD 相機控制器，Logic HD Lite 相機控制器，Logic 4K 相機控制器，5525 控制器適配器

K 號：K200617 · 2020-06-23

申請人Richard Wolf Medical Instruments Corporation
決定日期2020-06-23
產品代碼FET
諮詢委員會GU
決定相當於

器材摘要

Logic HD Camera Controller, Logic HD Lite Camera Controller, Logic 4K Camera Contoller, Adapter for Controller 5525 is the device name listed in this FDA 510(k) record. The listed applicant is Richard Wolf Medical Instruments Corporation. It received FDA 510(k) clearance on 2020-06-23 under 510(k) number K200617. The device is classified under product code FET. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Logic HD Camera Controller, Logic HD Lite Camera Controller, Logic 4K Camera Contoller, Adapter for Controller 5525?

Logic HD Camera Controller, Logic HD Lite Camera Controller, Logic 4K Camera Contoller, Adapter for Controller 5525 is a medical device that received FDA 510(k) clearance on 2020-06-23. The listed applicant is Richard Wolf Medical Instruments Corporation. The 510(k) number is K200617.

When did Logic HD Camera Controller, Logic HD Lite Camera Controller, Logic 4K Camera Contoller, Adapter for Controller 5525 receive FDA 510(k) clearance?

Logic HD Camera Controller, Logic HD Lite Camera Controller, Logic 4K Camera Contoller, Adapter for Controller 5525 received FDA 510(k) clearance on 2020-06-23, under 510(k) number K200617.

Who is the listed applicant for Logic HD Camera Controller, Logic HD Lite Camera Controller, Logic 4K Camera Contoller, Adapter for Controller 5525?

The FDA 510(k) record lists Richard Wolf Medical Instruments Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Logic HD Camera Controller, Logic HD Lite Camera Controller, Logic 4K Camera Contoller, Adapter for Controller 5525?

The FDA product code for Logic HD Camera Controller, Logic HD Lite Camera Controller, Logic 4K Camera Contoller, Adapter for Controller 5525 is FET.

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 Richard Wolf Medical Instruments 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。

K231291穿孔籃K230194HF外科電刀 400KHZK212808Logic Hd 相機頭綠色，系統綠色K211332D 相機控制器K203226望遠鏡 0 O 10MM WL 305MM / 望遠鏡 30 O 10MM WL 305MM / 望遠鏡 50 O 10MM WL 305MM，望遠鏡 0 O 10MM WL 440MM / 望遠鏡 30 O 10MM WL 440MM / 望遠鏡 50 O 10MM WL 440MMK201897感應-輸尿管鏡 9 FR WL 600 MM（短RIWO D-URS），控制器用适配器 5525

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相關器械（代碼：FET）

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。

K2620794K攝影鏡頭 OLYMPUS CH-S700-08-LB 医療設備規範文本Olympus Medical Systems Corp.K261880富士通電子處理器EP-8000；氣球控制器PB-30；內視鏡輔助程序EW10-VM01Fujifilm CorporationK261260HD攝影鏡頭 OLYMPUS CH-S200-08-LBOlympus Medical Systems CorporationK251734ProVee影片處理單元（PV-003）Proverum LimitedK250462UL UHD-Clear View 4K攝影系統（UL-3Chip 4K）Univlabs Technologies Private LimitedK250204內視鏡攝影系統Shenzhen Sophway Technology Co., Ltd.

官方來源

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