FDA 510(k)

LCD 显示器 (HMD3C21S), LCD 显示器 (HMD5G21S)

K号: K221567 · 2022-07-26

申请人Qingdao Hisense Medical Equipment Co., Ltd.

决定日期2022-07-26

产品代码PGY

咨询委员会RA

决定实质等同

器械摘要

LCD monitor (HMD3C21S), LCD monitor (HMD5G21S) 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 2022-07-26 under 510(k) number K221567. The device is classified under product code PGY. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the LCD monitor (HMD3C21S), LCD monitor (HMD5G21S)?

LCD monitor (HMD3C21S), LCD monitor (HMD5G21S) is a medical device that received FDA 510(k) clearance on 2022-07-26. The listed applicant is Qingdao Hisense Medical Equipment Co., Ltd.. The 510(k) number is K221567.

When did LCD monitor (HMD3C21S), LCD monitor (HMD5G21S) receive FDA 510(k) clearance?

LCD monitor (HMD3C21S), LCD monitor (HMD5G21S) received FDA 510(k) clearance on 2022-07-26, under 510(k) number K221567.

Who is the listed applicant for LCD monitor (HMD3C21S), LCD monitor (HMD5G21S)?

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 LCD monitor (HMD3C21S), LCD monitor (HMD5G21S)?

The FDA product code for LCD monitor (HMD3C21S), LCD monitor (HMD5G21S) is PGY.

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。

K233841HD80系列超声诊断系统 K233439HD60系列超声诊断系统 K222208Hisense LCD 监视器 HMD2C21A, HMD4C27S, HMD6C30D K222132Hisense LCD 监视器 HMD2G21S, HMD3G21S 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 →

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。