SIGNA Artist Evo
K号: K213603 · 2022-02-11
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器械摘要
SIGNA Artist Evo is the device name listed in this FDA 510(k) record. The listed applicant is Ge Healthcare (Tianjin) Company Limited. It received FDA 510(k) clearance on 2022-02-11 under 510(k) number K213603. 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 Artist Evo?
SIGNA Artist Evo is a medical device that received FDA 510(k) clearance on 2022-02-11. The listed applicant is Ge Healthcare (Tianjin) Company Limited. The 510(k) number is K213603.
When did SIGNA Artist Evo receive FDA 510(k) clearance?
SIGNA Artist Evo received FDA 510(k) clearance on 2022-02-11, under 510(k) number K213603.
Who is the listed applicant for SIGNA Artist Evo?
The FDA 510(k) record lists Ge Healthcare (Tianjin) Company Limited as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for SIGNA Artist Evo?
The FDA product code for SIGNA Artist Evo is LNH.
相关临床试验
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列明Ge Healthcare (Tianjin) Company Limited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。
相关器械（代码：LNH）
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。
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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。
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