FDA 510(k)

相機系統（相機控制單元、將與光纖內視鏡相連的相機頭），近紅外線光源

K 號：K221591 · 2023-02-23

決定日期2023-02-23

產品代碼GCJ

諮詢委員會GU

決定相當於

器材摘要

Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope), NIR FI Light Source is the device name listed in this FDA 510(k) record. The listed applicant is Schoelly Fiberoptic GmbH. It received FDA 510(k) clearance on 2023-02-23 under 510(k) number K221591. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope), NIR FI Light Source?

Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope), NIR FI Light Source is a medical device that received FDA 510(k) clearance on 2023-02-23. The listed applicant is Schoelly Fiberoptic GmbH. The 510(k) number is K221591.

When did Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope), NIR FI Light Source receive FDA 510(k) clearance?

Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope), NIR FI Light Source received FDA 510(k) clearance on 2023-02-23, under 510(k) number K221591.

Who is the listed applicant for Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope), NIR FI Light Source?

The FDA 510(k) record lists Schoelly Fiberoptic GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope), NIR FI Light Source?

The FDA product code for Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope), NIR FI Light Source is GCJ.

其他以 Schoelly Fiberoptic GmbH 為申請人之記錄

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K233225SCHOELLY 氧飽和成像 (OSI) 相機系統（相機控制單元，相機頭將與光纖內視鏡相連接）K201617TipVision視覺內視鏡系統（TipVision VideoScope 0°/30°；EleVision HD 2 開關控制單元（CCU））K201970Schoelly 腹腔鏡/宮腔鏡及附件 K151308Schoelly腎鏡組合，Schoelly超迷你腎鏡組合

相關器械（代碼：GCJ）

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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官方來源

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