UL UHD-Clear View 4K摄像头系统（UL-3Chip 4K）
K号: K250462 · 2025-08-11
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决定日期2025-08-11
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
UL UHD-Clear View 4K Camera System (UL-3Chip 4K) is the device name listed in this FDA 510(k) record. The listed applicant is Univlabs Technologies Private Limited. It received FDA 510(k) clearance on 2025-08-11 under 510(k) number K250462. 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 UL UHD-Clear View 4K Camera System (UL-3Chip 4K)?
UL UHD-Clear View 4K Camera System (UL-3Chip 4K) is a medical device that received FDA 510(k) clearance on 2025-08-11. The listed applicant is Univlabs Technologies Private Limited. The 510(k) number is K250462.
When did UL UHD-Clear View 4K Camera System (UL-3Chip 4K) receive FDA 510(k) clearance?
UL UHD-Clear View 4K Camera System (UL-3Chip 4K) received FDA 510(k) clearance on 2025-08-11, under 510(k) number K250462.
Who is the listed applicant for UL UHD-Clear View 4K Camera System (UL-3Chip 4K)?
The FDA 510(k) record lists Univlabs Technologies Private Limited as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for UL UHD-Clear View 4K Camera System (UL-3Chip 4K)?
The FDA product code for UL UHD-Clear View 4K Camera System (UL-3Chip 4K) is FET.
相关临床试验
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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。
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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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