FDA 510(k)

Sonic DL

K号: K223523 · 2023-05-30

申请人Ge Medical Systems,Llc (Ge Healthcare)

决定日期2023-05-30

产品代码LNH

咨询委员会RA

决定实质等同

器械摘要

Sonic DL is the device name listed in this FDA 510(k) record. The listed applicant is Ge Medical Systems,Llc (Ge Healthcare). It received FDA 510(k) clearance on 2023-05-30 under 510(k) number K223523. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Sonic DL?

Sonic DL is a medical device that received FDA 510(k) clearance on 2023-05-30. The listed applicant is Ge Medical Systems,Llc (Ge Healthcare). The 510(k) number is K223523.

When did Sonic DL receive FDA 510(k) clearance?

Sonic DL received FDA 510(k) clearance on 2023-05-30, under 510(k) number K223523.

Who is the listed applicant for Sonic DL?

The FDA 510(k) record lists Ge Medical Systems,Llc (Ge Healthcare) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sonic DL?

The FDA product code for Sonic DL is LNH.

列明Ge Medical Systems,Llc (Ge Healthcare)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。

K213717AIR Recon DL

官方来源

在 FDA 数据库中查看 →

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。