FDA 510(k)

压平眼压计

K号: K142263 · 2016-04-15

申请人Shanghai Mediworks Precision Instruments Co. , Ltd.

决定日期2016-04-15

产品代码HKY

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决定实质等同

器械摘要

Applanation Tonometer 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 2016-04-15 under 510(k) number K142263. The device is classified under product code HKY. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Applanation Tonometer?

Applanation Tonometer is a medical device that received FDA 510(k) clearance on 2016-04-15. The listed applicant is Shanghai Mediworks Precision Instruments Co. , Ltd.. The 510(k) number is K142263.

When did Applanation Tonometer receive FDA 510(k) clearance?

Applanation Tonometer received FDA 510(k) clearance on 2016-04-15, under 510(k) number K142263.

Who is the listed applicant for Applanation Tonometer?

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 Applanation Tonometer?

The FDA product code for Applanation Tonometer is HKY.

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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