FDA 510(k)

3D OCT-1 Maestro

K号: K161509 · 2016-07-28

决定日期2016-07-28

产品代码OBO

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

3D OCT-1 Maestro is the device name listed in this FDA 510(k) record. The listed applicant is Topcon Corporation. It received FDA 510(k) clearance on 2016-07-28 under 510(k) number K161509. The device is classified under product code OBO. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the 3D OCT-1 Maestro?

3D OCT-1 Maestro is a medical device that received FDA 510(k) clearance on 2016-07-28. The listed applicant is Topcon Corporation. The 510(k) number is K161509.

When did 3D OCT-1 Maestro receive FDA 510(k) clearance?

3D OCT-1 Maestro received FDA 510(k) clearance on 2016-07-28, under 510(k) number K161509.

Who is the listed applicant for 3D OCT-1 Maestro?

FDA 510(k)记录显示Topcon 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 3D OCT-1 Maestro?

The FDA product code for 3D OCT-1 Maestro is OBO.

列明Topcon 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。

K262637裂隙灯 SL-D4（类型：LED）K253039AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIA K2410813D 光相干断层扫描 3D OCT-1 (类型：Maestro2)；IMAGEnet6 眼科数据系统 K2335613D 光学相干断层扫描 (3D OCT-1(type: Maestro2))K232828IMAGEnet6 眼科数据系统 K2312223D 光相干断层扫描 3D OCT-1(type: Maestro2)

查看所有 12 个设备 →

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。