FDA 510(k)

SIGNA Hero

K号: K213668 · 2022-01-20

申请人Ge Healthcare (Ge Medical Systems, LLC)

决定日期2022-01-20

产品代码LNH

咨询委员会RA

决定实质等同

器械摘要

SIGNA Hero is the device name listed in this FDA 510(k) record. The listed applicant is Ge Healthcare (Ge Medical Systems, LLC). It received FDA 510(k) clearance on 2022-01-20 under 510(k) number K213668. 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 SIGNA Hero?

SIGNA Hero is a medical device that received FDA 510(k) clearance on 2022-01-20. The listed applicant is Ge Healthcare (Ge Medical Systems, LLC). The 510(k) number is K213668.

When did SIGNA Hero receive FDA 510(k) clearance?

SIGNA Hero received FDA 510(k) clearance on 2022-01-20, under 510(k) number K213668.

Who is the listed applicant for SIGNA Hero?

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

What is the FDA product code for SIGNA Hero?

The FDA product code for SIGNA Hero is LNH.

列明Ge Healthcare (Ge Medical Systems, LLC)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。

K202966SIGNA 架构师 K193282SIGNA Premier

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。