Twoplus 施用器
K号: K232579 · 2023-12-21
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决定日期2023-12-21
产品代码QYZ
咨询委员会OB
请注意，由于您没有提供具体的医疗设备监管文本，我无法进行翻译。请提供具体的文本内容，以便我能够按照您的要求进行翻译。
决定实质等同
器械摘要
Twoplus Applicator is the device name listed in this FDA 510(k) record. The listed applicant is Hannah Life Technologies Pte , Ltd.. It received FDA 510(k) clearance on 2023-12-21 under 510(k) number K232579. The device is classified under product code QYZ. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Twoplus Applicator?
Twoplus Applicator is a medical device that received FDA 510(k) clearance on 2023-12-21. The listed applicant is Hannah Life Technologies Pte , Ltd.. The 510(k) number is K232579.
When did Twoplus Applicator receive FDA 510(k) clearance?
Twoplus Applicator received FDA 510(k) clearance on 2023-12-21, under 510(k) number K232579.
Who is the listed applicant for Twoplus Applicator?
The FDA 510(k) record lists Hannah Life Technologies Pte , Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Twoplus Applicator?
The FDA product code for Twoplus Applicator is QYZ.
相关临床试验
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相关器械（代码：QYZ）
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。
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