FDA 510(k)

Accuro 3S

K号: K243937 · 2025-05-23

决定日期2025-05-23

产品代码IYO

咨询委员会RA

决定实质等同

器械摘要

Accuro 3S is the device name listed in this FDA 510(k) record. The listed applicant is Rivanna Medical, Inc.. It received FDA 510(k) clearance on 2025-05-23 under 510(k) number K243937. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

什么是Accuro 3S？

Accuro 3S is a medical device that received FDA 510(k) clearance on 2025-05-23. The listed applicant is Rivanna Medical, Inc.. The 510(k) number is K243937.

Accuro 3S何时获得FDA 510(k)批准？

Accuro 3S received FDA 510(k) clearance on 2025-05-23, under 510(k) number K243937.

Accuro 3S的申请人是谁？

FDA 510(k)记录中列出Rivanna Medical, Inc.为申请人。这本身并不足以确立该设备制造商的身份。

Accuro 3S的FDA产品代码是什么？

FDA产品代码为Accuro 3S的是IYO。

列明Rivanna Medical, Inc.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。

K253452Accuro 3S K261014Accuro® 3S 针引导套件 K254021Accuro XV K250469Accuro® 3S 针引导套件

官方来源

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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。