3D Accuitomo 150N
K号: K201378 · 2021-02-18
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器械摘要
3D Accuitomo 150N is the device name listed in this FDA 510(k) record. The listed applicant is J. Morita USA, Inc.. It received FDA 510(k) clearance on 2021-02-18 under 510(k) number K201378. The device is classified under product code OAS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the 3D Accuitomo 150N?
3D Accuitomo 150N is a medical device that received FDA 510(k) clearance on 2021-02-18. The listed applicant is J. Morita USA, Inc.. The 510(k) number is K201378.
When did 3D Accuitomo 150N receive FDA 510(k) clearance?
3D Accuitomo 150N received FDA 510(k) clearance on 2021-02-18, under 510(k) number K201378.
Who is the listed applicant for 3D Accuitomo 150N?
The FDA 510(k) record lists J. Morita USA, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for 3D Accuitomo 150N?
The FDA product code for 3D Accuitomo 150N is OAS.
相关临床试验
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列明J. Morita USA, Inc.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：OAS）
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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