HPR 无线卫生手柄
K号: K243911 · 2024-12-20
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决定日期2024-12-20
产品代码EKX
咨询委员会DE
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决定实质等同
器械摘要
HPR Cordless Hygiene Handpiece is the device name listed in this FDA 510(k) record. The listed applicant is Handpiece Headquarters. It received FDA 510(k) clearance on 2024-12-20 under 510(k) number K243911. The device is classified under product code EKX. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the HPR Cordless Hygiene Handpiece?
HPR Cordless Hygiene Handpiece is a medical device that received FDA 510(k) clearance on 2024-12-20. The listed applicant is Handpiece Headquarters. The 510(k) number is K243911.
When did HPR Cordless Hygiene Handpiece receive FDA 510(k) clearance?
HPR Cordless Hygiene Handpiece received FDA 510(k) clearance on 2024-12-20, under 510(k) number K243911.
Who is the listed applicant for HPR Cordless Hygiene Handpiece?
The FDA 510(k) record lists Handpiece Headquarters as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for HPR Cordless Hygiene Handpiece?
The FDA product code for HPR Cordless Hygiene Handpiece is EKX.
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Handpiece Headquarters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：EKX）
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。
K261987可重复使用智能针Osstell ABK252223Alpha Endo手柄（Alpha Endo）SHENZHEN SUPERLINE TECHNOLOGY CO., LTD.K251597InnerView 系统Perimetrics, Inc.K243692EnDrive（EnDriveUS）Advanced Technology Research (A.T.R.) S.R.L.K242514Endo电机（E-LITE MAX，E-LITE PRO，E-LITE INO）Shenzhen Rogin Medical Co., Ltd.K241065ChecQ (AC100)Dentis Co., Ltd.
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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