1.5T HD T/R 膝关节阵列（10-F34127）
K号: K231085 · 2023-08-18
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器械摘要
1.5T HD T/R Knee Array (10-F34127) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen RF Tech Co., Ltd.. It received FDA 510(k) clearance on 2023-08-18 under 510(k) number K231085. The device is classified under product code MOS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the 1.5T HD T/R Knee Array (10-F34127)?
1.5T HD T/R Knee Array (10-F34127) is a medical device that received FDA 510(k) clearance on 2023-08-18. The listed applicant is Shenzhen RF Tech Co., Ltd.. The 510(k) number is K231085.
When did 1.5T HD T/R Knee Array (10-F34127) receive FDA 510(k) clearance?
1.5T HD T/R Knee Array (10-F34127) received FDA 510(k) clearance on 2023-08-18, under 510(k) number K231085.
Who is the listed applicant for 1.5T HD T/R Knee Array (10-F34127)?
The FDA 510(k) record lists Shenzhen RF Tech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for 1.5T HD T/R Knee Array (10-F34127)?
The FDA product code for 1.5T HD T/R Knee Array (10-F34127) is MOS.
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。
列明Shenzhen RF Tech Co., Ltd.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：MOS）
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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