FDA 510(k)

HD80系列超声诊断系统

K号: K233841 · 2024-05-16

申请人Qingdao Hisense Medical Equipment Co., Ltd.

决定日期2024-05-16

产品代码IYN

咨询委员会RA

决定实质等同

器械摘要

HD80 Series Ultrasound Diagnostic System is the device name listed in this FDA 510(k) record. The listed applicant is Qingdao Hisense Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2024-05-16 under 510(k) number K233841. 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 HD80 Series Ultrasound Diagnostic System?

HD80 Series Ultrasound Diagnostic System is a medical device that received FDA 510(k) clearance on 2024-05-16. The listed applicant is Qingdao Hisense Medical Equipment Co., Ltd.. The 510(k) number is K233841.

When did HD80 Series Ultrasound Diagnostic System receive FDA 510(k) clearance?

HD80 Series Ultrasound Diagnostic System received FDA 510(k) clearance on 2024-05-16, under 510(k) number K233841.

Who is the listed applicant for HD80 Series Ultrasound Diagnostic System?

The FDA 510(k) record lists Qingdao Hisense Medical Equipment Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HD80 Series Ultrasound Diagnostic System?

The FDA product code for HD80 Series Ultrasound Diagnostic System is IYN.

列明Qingdao Hisense Medical Equipment Co., Ltd.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。

K233439HD60系列超声诊断系统 K222208Hisense LCD 监视器 HMD2C21A, HMD4C27S, HMD6C30D K222132Hisense LCD 监视器 HMD2G21S, HMD3G21S K221567LCD 显示器 (HMD3C21S), LCD 显示器 (HMD5G21S)K213862HD60系列超声诊断系统 K160347Hisense LDC 监视器型号 HMD2G21/HMD3G21/HMD5G21

查看所有 7 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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