TOTIM 患者固定垫固定系统
K号: K190894 · 2019-04-30
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器械摘要
TOTIM Patient Cushion Immobilization System is the device name listed in this FDA 510(k) record. The listed applicant is Essebi Medical Srl. It received FDA 510(k) clearance on 2019-04-30 under 510(k) number K190894. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the TOTIM Patient Cushion Immobilization System?
TOTIM Patient Cushion Immobilization System is a medical device that received FDA 510(k) clearance on 2019-04-30. The listed applicant is Essebi Medical Srl. The 510(k) number is K190894.
When did TOTIM Patient Cushion Immobilization System receive FDA 510(k) clearance?
TOTIM Patient Cushion Immobilization System received FDA 510(k) clearance on 2019-04-30, under 510(k) number K190894.
Who is the listed applicant for TOTIM Patient Cushion Immobilization System?
The FDA 510(k) record lists Essebi Medical Srl as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for TOTIM Patient Cushion Immobilization System?
The FDA product code for TOTIM Patient Cushion Immobilization System is IYE.
相关临床试验
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相关器械（代码：IYE）
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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