3D-SHAPER
K号: K220822 · 2022-12-09
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器械摘要
3D-SHAPER is the device name listed in this FDA 510(k) record. The listed applicant is 3D-Shaper Medical S.L. It received FDA 510(k) clearance on 2022-12-09 under 510(k) number K220822. The device is classified under product code KGI. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the 3D-SHAPER?
3D-SHAPER is a medical device that received FDA 510(k) clearance on 2022-12-09. The listed applicant is 3D-Shaper Medical S.L. The 510(k) number is K220822.
When did 3D-SHAPER receive FDA 510(k) clearance?
3D-SHAPER received FDA 510(k) clearance on 2022-12-09, under 510(k) number K220822.
Who is the listed applicant for 3D-SHAPER?
The FDA 510(k) record lists 3D-Shaper Medical S.L as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for 3D-SHAPER?
The FDA product code for 3D-SHAPER is KGI.
相关临床试验
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列明3D-Shaper Medical S.L为申报人的其他记录
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相关器械（代码：KGI）
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
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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