FDA 510(k)

MICROPERIMETER MP-3

K号: K152729 · 2016-06-06

决定日期2016-06-06

产品代码HKI

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

MICROPERIMETER MP-3 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 2016-06-06 under 510(k) number K152729. The device is classified under product code HKI. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the MICROPERIMETER MP-3?

MICROPERIMETER MP-3 is a medical device that received FDA 510(k) clearance on 2016-06-06. The listed applicant is Nidek Co., Ltd.. The 510(k) number is K152729.

When did MICROPERIMETER MP-3 receive FDA 510(k) clearance?

MICROPERIMETER MP-3 received FDA 510(k) clearance on 2016-06-06, under 510(k) number K152729.

Who is the listed applicant for MICROPERIMETER MP-3?

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 MICROPERIMETER MP-3?

The FDA product code for MICROPERIMETER MP-3 is HKI.

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。

K221320扫描激光检眼镜Mirante [SLO/OCT型号]带图像归档软件NAVIS-EX；扫描激光检眼镜Mirante [SLO型号]带图像归档软件NAVIS-EX K203130眼科Yag激光系统YC-200 K192045眼科Yag激光系统YC-200 K190198Microperimeter MP-3, Microperimeter MP-3 Type S K181345Image Filing Software NAVIS-EX K173980Specular 显微镜 CEM-530

查看所有 11 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。