FDA 510(k)

图像处理单元，型号：OPTO-CAM104K，摄像头头，型号：OPTO-CHD104KH

K号: K221781 · 2023-02-02

申请人Guangdong Optomedic Technologies, Inc.

决定日期2023-02-02

产品代码GCJ

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决定实质等同

器械摘要

Image Processing Unit, Model: OPTO-CAM104K, Camera Head, Model: OPTO-CHD104KH is the device name listed in this FDA 510(k) record. The listed applicant is Guangdong Optomedic Technologies, Inc.. It received FDA 510(k) clearance on 2023-02-02 under 510(k) number K221781. 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 Image Processing Unit, Model: OPTO-CAM104K, Camera Head, Model: OPTO-CHD104KH?

Image Processing Unit, Model: OPTO-CAM104K, Camera Head, Model: OPTO-CHD104KH is a medical device that received FDA 510(k) clearance on 2023-02-02. The listed applicant is Guangdong Optomedic Technologies, Inc.. The 510(k) number is K221781.

When did Image Processing Unit, Model: OPTO-CAM104K, Camera Head, Model: OPTO-CHD104KH receive FDA 510(k) clearance?

Image Processing Unit, Model: OPTO-CAM104K, Camera Head, Model: OPTO-CHD104KH received FDA 510(k) clearance on 2023-02-02, under 510(k) number K221781.

Who is the listed applicant for Image Processing Unit, Model: OPTO-CAM104K, Camera Head, Model: OPTO-CHD104KH?

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

What is the FDA product code for Image Processing Unit, Model: OPTO-CAM104K, Camera Head, Model: OPTO-CHD104KH?

The FDA product code for Image Processing Unit, Model: OPTO-CAM104K, Camera Head, Model: OPTO-CHD104KH is GCJ.

列明Guangdong Optomedic Technologies, Inc.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。

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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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