FDA 510(k)

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

K号: K221591 · 2023-02-23

决定日期2023-02-23

产品代码GCJ

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决定实质等同

器械摘要

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.

常见问题

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.

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。

K233225SCHOELLY 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）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。

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官方来源

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