FDA 510(k)

EPIQ 诊断超声系统

K号: K200304 · 2020-03-06

决定日期2020-03-06

产品代码IYN

咨询委员会RA

决定实质等同

器械摘要

EPIQ Diagnostic Ultrasound System is the device name listed in this FDA 510(k) record. The listed applicant is Philips Ultrasound, Inc.. It received FDA 510(k) clearance on 2020-03-06 under 510(k) number K200304. 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 EPIQ Diagnostic Ultrasound System?

EPIQ Diagnostic Ultrasound System is a medical device that received FDA 510(k) clearance on 2020-03-06. The listed applicant is Philips Ultrasound, Inc.. The 510(k) number is K200304.

When did EPIQ Diagnostic Ultrasound System receive FDA 510(k) clearance?

EPIQ Diagnostic Ultrasound System received FDA 510(k) clearance on 2020-03-06, under 510(k) number K200304.

Who is the listed applicant for EPIQ Diagnostic Ultrasound System?

The FDA 510(k) record lists Philips Ultrasound, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EPIQ Diagnostic Ultrasound System?

The FDA product code for EPIQ Diagnostic Ultrasound System is IYN.

列明Philips Ultrasound, Inc.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。

K212777Collaboration Live K203406Lumify 诊断超声系统 K200603AAA 模型 K201665Collaboration Live K202216EPIQ 系列诊断超声系统 K201053PercuNav图像融合和介入导航

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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。

官方来源

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