HD 摄像头 OLYMPUS CH-S200-08-LB
K号: K261260 · 2026-06-24
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决定日期2026-06-24
产品代码FET
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
HD Camera Head OLYMPUS CH-S200-08-LB is the device name listed in this FDA 510(k) record. The listed applicant is Olympus Medical Systems Corporation. It received FDA 510(k) clearance on 2026-06-24 under 510(k) number K261260. The device is classified under product code FET. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the HD Camera Head OLYMPUS CH-S200-08-LB?
HD Camera Head OLYMPUS CH-S200-08-LB is a medical device that received FDA 510(k) clearance on 2026-06-24. The listed applicant is Olympus Medical Systems Corporation. The 510(k) number is K261260.
When did HD Camera Head OLYMPUS CH-S200-08-LB receive FDA 510(k) clearance?
HD Camera Head OLYMPUS CH-S200-08-LB received FDA 510(k) clearance on 2026-06-24, under 510(k) number K261260.
Who is the listed applicant for HD Camera Head OLYMPUS CH-S200-08-LB?
FDA 510(k)记录显示，Olympus Medical Systems Corporation为申请人。这本身并不能确立该设备制造商的身份。
What is the FDA product code for HD Camera Head OLYMPUS CH-S200-08-LB?
The FDA product code for HD Camera Head OLYMPUS CH-S200-08-LB is FET.
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。
列明Olympus Medical Systems Corporation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。
相关器械（代码：FET）
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。
K2620794K摄像头头 OLYMPUS CH-S700-08-LBOlympus Medical Systems Corp.K261880FUJIFILM 处理器 EP-8000；球囊控制器 PB-30；内窥镜支持程序 EW10-VM01Fujifilm CorporationK251734ProVee视频处理单元（PV-003）Proverum LimitedK250462UL UHD-Clear View 4K摄像头系统（UL-3Chip 4K）Univlabs Technologies Private LimitedK250204内窥镜摄像头系统Shenzhen Sophway Technology Co., Ltd.K243260富士胶片处理器EP-8000; 富士胶片内窥镜型号EG-860RFujifilm Corporation
官方来源
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
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