EyeBOX (型号EBX-4)
K号: K212310 · 2021-12-22
广告
决定日期2021-12-22
产品代码QEA
咨询委员会NE
请注意，您提供的文本“NE”不足以进行翻译，因为它不是一个完整的句子或描述。请提供完整的医疗设备监管文本，以便我能够进行准确的翻译。
决定实质等同
器械摘要
EyeBOX (Model EBX-4) is the device name listed in this FDA 510(k) record. The listed applicant is Oculogica, Inc.. It received FDA 510(k) clearance on 2021-12-22 under 510(k) number K212310. The device is classified under product code QEA. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the EyeBOX (Model EBX-4)?
EyeBOX (Model EBX-4) is a medical device that received FDA 510(k) clearance on 2021-12-22. The listed applicant is Oculogica, Inc.. The 510(k) number is K212310.
When did EyeBOX (Model EBX-4) receive FDA 510(k) clearance?
EyeBOX (Model EBX-4) received FDA 510(k) clearance on 2021-12-22, under 510(k) number K212310.
Who is the listed applicant for EyeBOX (Model EBX-4)?
The FDA 510(k) record lists Oculogica, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for EyeBOX (Model EBX-4)?
The FDA product code for EyeBOX (Model EBX-4) is QEA.
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Oculogica, 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。
相关器械（代码：QEA）
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