FDA 510(k)

Corin 优化定位系统 (OPS)

K号: K152893 · 2016-06-03

决定日期2016-06-03

产品代码LZO

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决定实质等同

器械摘要

Corin Optimized Positioning System (OPS) is the device name listed in this FDA 510(k) record. The listed applicant is Corin USA. It received FDA 510(k) clearance on 2016-06-03 under 510(k) number K152893. The device is classified under product code LZO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Corin Optimized Positioning System (OPS)?

Corin Optimized Positioning System (OPS) is a medical device that received FDA 510(k) clearance on 2016-06-03. The listed applicant is Corin USA. The 510(k) number is K152893.

When did Corin Optimized Positioning System (OPS) receive FDA 510(k) clearance?

Corin Optimized Positioning System (OPS) received FDA 510(k) clearance on 2016-06-03, under 510(k) number K152893.

Who is the listed applicant for Corin Optimized Positioning System (OPS)?

The FDA 510(k) record lists Corin USA as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Corin Optimized Positioning System (OPS)?

The FDA product code for Corin Optimized Positioning System (OPS) is LZO.

列明Corin USA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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官方来源

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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。