FDA 510(k)

Vscan Extend

K号: K161588 · 2016-08-31

申请人GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC

决定日期2016-08-31

产品代码IYN

咨询委员会RA

决定实质等同

器械摘要

Vscan Extend is the device name listed in this FDA 510(k) record. The listed applicant is GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC. It received FDA 510(k) clearance on 2016-08-31 under 510(k) number K161588. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Vscan Extend?

Vscan Extend is a medical device that received FDA 510(k) clearance on 2016-08-31. The listed applicant is GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC. The 510(k) number is K161588.

When did Vscan Extend receive FDA 510(k) clearance?

Vscan Extend received FDA 510(k) clearance on 2016-08-31, under 510(k) number K161588.

Who is the listed applicant for Vscan Extend?

The FDA 510(k) record lists GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Vscan Extend?

The FDA product code for Vscan Extend is IYN.

列明GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC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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相关器械（代码：IYN）

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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