FDA 510(k)

SonoSite Edge II超声系统

K号: K153626 · 2016-01-20

决定日期2016-01-20

产品代码IYN

咨询委员会RA

决定实质等同

器械摘要

SonoSite Edge II Ultrasound System is the device name listed in this FDA 510(k) record. The listed applicant is FUJIFILM Sonosite, Inc.. It received FDA 510(k) clearance on 2016-01-20 under 510(k) number K153626. 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 SonoSite Edge II Ultrasound System?

SonoSite Edge II Ultrasound System is a medical device that received FDA 510(k) clearance on 2016-01-20. The listed applicant is FUJIFILM Sonosite, Inc.. The 510(k) number is K153626.

When did SonoSite Edge II Ultrasound System receive FDA 510(k) clearance?

SonoSite Edge II Ultrasound System received FDA 510(k) clearance on 2016-01-20, under 510(k) number K153626.

Who is the listed applicant for SonoSite Edge II Ultrasound System?

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

What is the FDA product code for SonoSite Edge II Ultrasound System?

The FDA product code for SonoSite Edge II Ultrasound System is IYN.

列明FUJIFILM Sonosite, 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。

K260595Sonosite iLOOK 超声系统 K253448Sonosite MT 超声系统 K251106Sonosite LX 和 Sonosite PX 超声系统 K251830Sonosite LX 超声系统 K233597Sonosite LX 超声系统 K213763Sonosite PX 超声系统

查看所有 19 个设备 →

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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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。