Specular 显微镜 CEM- 530
K号: K151706 · 2016-03-17
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决定日期2016-03-17
产品代码NQE
咨询委员会OP
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决定实质等同
器械摘要
Specular Microscope CEM- 530 is the device name listed in this FDA 510(k) record. The listed applicant is Nidek Co., Ltd.. It received FDA 510(k) clearance on 2016-03-17 under 510(k) number K151706. The device is classified under product code NQE. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Specular Microscope CEM- 530?
Specular Microscope CEM- 530 is a medical device that received FDA 510(k) clearance on 2016-03-17. The listed applicant is Nidek Co., Ltd.. The 510(k) number is K151706.
When did Specular Microscope CEM- 530 receive FDA 510(k) clearance?
Specular Microscope CEM- 530 received FDA 510(k) clearance on 2016-03-17, under 510(k) number K151706.
Who is the listed applicant for Specular Microscope CEM- 530?
The FDA 510(k) record lists Nidek Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Specular Microscope CEM- 530?
The FDA product code for Specular Microscope CEM- 530 is NQE.
相关临床试验
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列明Nidek Co., Ltd.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：NQE）
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。
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