OcuMet Beacon (OCUB100)
K号: K241931 · 2025-04-22
广告
决定日期2025-04-22
产品代码MYC
咨询委员会OP
请注意，由于您没有提供具体的医疗设备监管文本，我无法进行翻译。请提供具体的文本内容，以便我能够按照您的要求进行翻译。
决定实质等同
器械摘要
OcuMet Beacon (OCUB100) is the device name listed in this FDA 510(k) record. The listed applicant is Ocusciences, Inc.. It received FDA 510(k) clearance on 2025-04-22 under 510(k) number K241931. The device is classified under product code MYC. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the OcuMet Beacon (OCUB100)?
OcuMet Beacon (OCUB100) is a medical device that received FDA 510(k) clearance on 2025-04-22. The listed applicant is Ocusciences, Inc.. The 510(k) number is K241931.
When did OcuMet Beacon (OCUB100) receive FDA 510(k) clearance?
OcuMet Beacon (OCUB100) received FDA 510(k) clearance on 2025-04-22, under 510(k) number K241931.
Who is the listed applicant for OcuMet Beacon (OCUB100)?
The FDA 510(k) record lists Ocusciences, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for OcuMet Beacon (OCUB100)?
The FDA product code for OcuMet Beacon (OCUB100) is MYC.
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。
相关器械（代码：MYC）
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。
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。
广告