KEOPS 3D平衡分析仪
K号: K213975 · 2022-05-06
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器械摘要
KEOPS Balance Analyzer 3D is the device name listed in this FDA 510(k) record. The listed applicant is S.M.A.I.O. It received FDA 510(k) clearance on 2022-05-06 under 510(k) number K213975. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the KEOPS Balance Analyzer 3D?
KEOPS Balance Analyzer 3D is a medical device that received FDA 510(k) clearance on 2022-05-06. The listed applicant is S.M.A.I.O. The 510(k) number is K213975.
When did KEOPS Balance Analyzer 3D receive FDA 510(k) clearance?
KEOPS Balance Analyzer 3D received FDA 510(k) clearance on 2022-05-06, under 510(k) number K213975.
Who is the listed applicant for KEOPS Balance Analyzer 3D?
FDA 510(k)记录中列出S.M.A.I.O为申请人。这本身并不能确立该设备制造商的身份。
What is the FDA product code for KEOPS Balance Analyzer 3D?
The FDA product code for KEOPS Balance Analyzer 3D is LLZ.
相关临床试验
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列明S.M.A.I.O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：LLZ）
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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请注意，由于您没有提供具体的医疗设备监管文本，我无法提供准确的翻译。如果您能提供具体的文本内容，我将能够为您提供准确的翻译。Taiwan Main Orthopaedic Biotechnology Co., Ltd.K261861SPINEsim v1.0Mdsim S.A.K2620603D-RD-SRadiopharmaceutical Imaging & Dosimetry, LLC
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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