FDA 510(k)

裂隙灯显微镜

K号: K152429 · 2016-05-11

申请人Shanghai Mediworks Precision Instruments Co. , Ltd.

决定日期2016-05-11

产品代码HJO

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决定实质等同

器械摘要

Slit Lamp Microscope is the device name listed in this FDA 510(k) record. The listed applicant is Shanghai Mediworks Precision Instruments Co. , Ltd.. It received FDA 510(k) clearance on 2016-05-11 under 510(k) number K152429. The device is classified under product code HJO. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Slit Lamp Microscope?

Slit Lamp Microscope is a medical device that received FDA 510(k) clearance on 2016-05-11. The listed applicant is Shanghai Mediworks Precision Instruments Co. , Ltd.. The 510(k) number is K152429.

When did Slit Lamp Microscope receive FDA 510(k) clearance?

Slit Lamp Microscope received FDA 510(k) clearance on 2016-05-11, under 510(k) number K152429.

Who is the listed applicant for Slit Lamp Microscope?

The FDA 510(k) record lists Shanghai Mediworks Precision Instruments Co. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Slit Lamp Microscope?

The FDA product code for Slit Lamp Microscope is HJO.

列明Shanghai Mediworks Precision Instruments 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。

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