Well-Root PT
K号: K252285 · 2025-09-19
广告
决定日期2025-09-19
产品代码KIF
咨询委员会DE
请注意,您没有提供具体的医疗设备监管文本内容,因此我无法进行翻译。请提供需要翻译的具体文本,我将根据您的要求进行翻译。
决定实质等同
器械摘要
Well-Root PT is the device name listed in this FDA 510(k) record. The listed applicant is Vericom Co., Ltd.. It received FDA 510(k) clearance on 2025-09-19 under 510(k) number K252285. The device is classified under product code KIF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Well-Root PT?
Well-Root PT is a medical device that received FDA 510(k) clearance on 2025-09-19. The listed applicant is Vericom Co., Ltd.. The 510(k) number is K252285.
When did Well-Root PT receive FDA 510(k) clearance?
Well-Root PT received FDA 510(k) clearance on 2025-09-19, under 510(k) number K252285.
Who is the listed applicant for Well-Root PT?
The FDA 510(k) record lists Vericom Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Well-Root PT?
The FDA product code for Well-Root PT is KIF.
列明Vericom 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:KIF)
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。
广告