Pivot 系统灭菌盒
K号: K181845 · 2019-11-25
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决定日期2019-11-25
产品代码KCT
咨询委员会医疗设备监管文本翻译如下：
HO
请注意，由于您没有提供具体的医疗设备监管文本内容，以上仅为示例。请提供具体的文本内容以便进行准确的翻译。
决定实质等同
器械摘要
Pivot System Sterilization case is the device name listed in this FDA 510(k) record. The listed applicant is Rp Medical, Inc.. It received FDA 510(k) clearance on 2019-11-25 under 510(k) number K181845. The device is classified under product code KCT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Pivot System Sterilization case?
Pivot System Sterilization case is a medical device that received FDA 510(k) clearance on 2019-11-25. The listed applicant is Rp Medical, Inc.. The 510(k) number is K181845.
When did Pivot System Sterilization case receive FDA 510(k) clearance?
Pivot System Sterilization case received FDA 510(k) clearance on 2019-11-25, under 510(k) number K181845.
Who is the listed applicant for Pivot System Sterilization case?
The FDA 510(k) record lists Rp Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Pivot System Sterilization case?
The FDA product code for Pivot System Sterilization case is KCT.
相关临床试验
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：KCT）
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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