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FDA 510(k)

SCHOELLY 氧饱和度成像 (OSI) 摄像机系统（摄像机控制单元，摄像机头需连接到光纤内窥镜）

K号: K233225 · 2024-06-20

申请人Schoelly Fiberoptic GmbH
决定日期2024-06-20
产品代码GCJ
咨询委员会GU 请注意，由于您只提供了“GU”这个词，我无法提供完整的翻译。如果您能提供完整的句子或段落，我将能够为您提供准确的翻译。
决定实质等同

器械摘要

SCHOELLY Oxygen Saturation Imaging (OSI) Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope) 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 2024-06-20 under 510(k) number K233225. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the SCHOELLY Oxygen Saturation Imaging (OSI) Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope)?

SCHOELLY Oxygen Saturation Imaging (OSI) Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope) is a medical device that received FDA 510(k) clearance on 2024-06-20. The listed applicant is Schoelly Fiberoptic GmbH. The 510(k) number is K233225.

When did SCHOELLY Oxygen Saturation Imaging (OSI) Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope) receive FDA 510(k) clearance?

SCHOELLY Oxygen Saturation Imaging (OSI) Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope) received FDA 510(k) clearance on 2024-06-20, under 510(k) number K233225.

Who is the listed applicant for SCHOELLY Oxygen Saturation Imaging (OSI) Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope)?

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 SCHOELLY Oxygen Saturation Imaging (OSI) Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope)?

The FDA product code for SCHOELLY Oxygen Saturation Imaging (OSI) Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope) is GCJ.

相关临床试验

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

列明Schoelly Fiberoptic GmbH为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K221591摄像头系统（摄像头控制单元，摄像头头连接到光纤内窥镜），NIR FI 光源K201617TipVision 视频内窥镜系统（TipVision 视频内窥镜 0°/30°；EleVision HD 2 摄像机控制单元（CCU））K201970Schoelly膀胱镜/宫腔镜及其附件K151308Schoelly肾镜套装，Schoelly超迷你肾镜套装

相关器械（代码：GCJ）

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K262397CuratOR EX2742Eizo CorporationK260884UNIDRIVE选择系统Karl Storz SE & CO. KGK260972OEV-271MUH 液晶显示器；OEV-321MUH 液晶显示器；OEV-431MUH 液晶显示器Sony CorporationK261139VereSee（VER150、VER200、VER151、VER201、VER200C和VER-100-103）Freyja Healthcare, LLCK253541EZ-Close™（EZ Close 端口部位闭合装置，EZ Close MAX 端口部位闭合装置，EZ Close II 端口部位闭合装置）Medical ImpactK261614LED液晶显示器（OEV-271H）Lg Electronics.Inc

官方来源

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