OK 手柄
K号: K221814 · 2022-07-15
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决定日期2022-07-15
产品代码EFB
咨询委员会DE
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决定实质等同
器械摘要
OK Handpiece is the device name listed in this FDA 510(k) record. The listed applicant is Jaintek Co.,Ltd. It received FDA 510(k) clearance on 2022-07-15 under 510(k) number K221814. The device is classified under product code EFB. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the OK Handpiece?
OK Handpiece is a medical device that received FDA 510(k) clearance on 2022-07-15. The listed applicant is Jaintek Co.,Ltd. The 510(k) number is K221814.
When did OK Handpiece receive FDA 510(k) clearance?
OK Handpiece received FDA 510(k) clearance on 2022-07-15, under 510(k) number K221814.
Who is the listed applicant for OK Handpiece?
The FDA 510(k) record lists Jaintek Co.,Ltd as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for OK Handpiece?
The FDA product code for OK Handpiece is EFB.
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。
相关器械（代码：EFB）
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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