FDA 510(k)

ScopeFlow Pure(™)

K号: K181418 · 2019-07-11

决定日期2019-07-11

产品代码OCX

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决定实质等同

器械摘要

ScopeFlow Pure(TM) is the device name listed in this FDA 510(k) record. The listed applicant is Partnership Medical Limited. It received FDA 510(k) clearance on 2019-07-11 under 510(k) number K181418. The device is classified under product code OCX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the ScopeFlow Pure(TM)?

ScopeFlow Pure(TM) is a medical device that received FDA 510(k) clearance on 2019-07-11. The listed applicant is Partnership Medical Limited. The 510(k) number is K181418.

When did ScopeFlow Pure(TM) receive FDA 510(k) clearance?

ScopeFlow Pure(TM) received FDA 510(k) clearance on 2019-07-11, under 510(k) number K181418.

Who is the listed applicant for ScopeFlow Pure(TM)?

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

What is the FDA product code for ScopeFlow Pure(TM)?

The FDA product code for ScopeFlow Pure(TM) is OCX.

列明Partnership Medical Limited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。

K181457EndoStream(TM)

官方来源

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