FDA 510(k)

场地；场地行；场地适；场地冲刺

K号: K251322 · 2025-07-25

申请人GE Medical Systems Ultrasound and Primary Care Diagnostics

决定日期2025-07-25

产品代码IYN

咨询委员会RA

决定实质等同

器械摘要

Venue; Venue Go; Venue Fit; Venue Sprint is the device name listed in this FDA 510(k) record. The listed applicant is GE Medical Systems Ultrasound and Primary Care Diagnostics. It received FDA 510(k) clearance on 2025-07-25 under 510(k) number K251322. 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 Venue; Venue Go; Venue Fit; Venue Sprint?

Venue; Venue Go; Venue Fit; Venue Sprint is a medical device that received FDA 510(k) clearance on 2025-07-25. The listed applicant is GE Medical Systems Ultrasound and Primary Care Diagnostics. The 510(k) number is K251322.

When did Venue; Venue Go; Venue Fit; Venue Sprint receive FDA 510(k) clearance?

Venue; Venue Go; Venue Fit; Venue Sprint received FDA 510(k) clearance on 2025-07-25, under 510(k) number K251322.

Who is the listed applicant for Venue; Venue Go; Venue Fit; Venue Sprint?

FDA 510(k)记录将GE医疗系统超声和初级护理诊断列为申请人。这本身并不足以确立设备制造商。

What is the FDA product code for Venue; Venue Go; Venue Fit; Venue Sprint?

The FDA product code for Venue; Venue Go; Venue Fit; Venue Sprint is IYN.

列明GE Medical Systems Ultrasound and Primary Care Diagnostics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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