UniVit HE，UniVit UHS
K号: K212763 · 2022-08-10
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决定日期2022-08-10
产品代码HQE
咨询委员会OP
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决定实质等同
器械摘要
UniVit HE, UniVit UHS is the device name listed in this FDA 510(k) record. The listed applicant is Visioncare Devices, LLC. It received FDA 510(k) clearance on 2022-08-10 under 510(k) number K212763. The device is classified under product code HQE. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the UniVit HE, UniVit UHS?
UniVit HE, UniVit UHS is a medical device that received FDA 510(k) clearance on 2022-08-10. The listed applicant is Visioncare Devices, LLC. The 510(k) number is K212763.
When did UniVit HE, UniVit UHS receive FDA 510(k) clearance?
UniVit HE, UniVit UHS received FDA 510(k) clearance on 2022-08-10, under 510(k) number K212763.
Who is the listed applicant for UniVit HE, UniVit UHS?
The FDA 510(k) record lists Visioncare Devices, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for UniVit HE, UniVit UHS?
The FDA product code for UniVit HE, UniVit UHS is HQE.
相关临床试验
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相关器械（代码：HQE）
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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