ACL TOP 970 CL
K号: K233790 · 2023-12-29
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决定日期2023-12-29
产品代码JPA
咨询委员会HE
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决定实质等同
器械摘要
ACL TOP 970 CL is the device name listed in this FDA 510(k) record. The listed applicant is Instrumentation Laboratory. It received FDA 510(k) clearance on 2023-12-29 under 510(k) number K233790. The device is classified under product code JPA. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the ACL TOP 970 CL?
ACL TOP 970 CL is a medical device that received FDA 510(k) clearance on 2023-12-29. The listed applicant is Instrumentation Laboratory. The 510(k) number is K233790.
When did ACL TOP 970 CL receive FDA 510(k) clearance?
ACL TOP 970 CL received FDA 510(k) clearance on 2023-12-29, under 510(k) number K233790.
Who is the listed applicant for ACL TOP 970 CL?
The FDA 510(k) record lists Instrumentation Laboratory as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for ACL TOP 970 CL?
The FDA product code for ACL TOP 970 CL is JPA.
相关器械(代码:JPA)
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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