Humask Pro Vision, Humask Pro Vision 3000
K号: K222551 · 2022-11-10
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决定日期2022-11-10
产品代码FXX
咨询委员会SU
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器械摘要
Humask Pro Vision, Humask Pro Vision 3000 is the device name listed in this FDA 510(k) record. The listed applicant is Entreprise Premont, Inc.. It received FDA 510(k) clearance on 2022-11-10 under 510(k) number K222551. The device is classified under product code FXX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Humask Pro Vision, Humask Pro Vision 3000?
Humask Pro Vision, Humask Pro Vision 3000 is a medical device that received FDA 510(k) clearance on 2022-11-10. The listed applicant is Entreprise Premont, Inc.. The 510(k) number is K222551.
When did Humask Pro Vision, Humask Pro Vision 3000 receive FDA 510(k) clearance?
Humask Pro Vision, Humask Pro Vision 3000 received FDA 510(k) clearance on 2022-11-10, under 510(k) number K222551.
Who is the listed applicant for Humask Pro Vision, Humask Pro Vision 3000?
The FDA 510(k) record lists Entreprise Premont, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Humask Pro Vision, Humask Pro Vision 3000?
The FDA product code for Humask Pro Vision, Humask Pro Vision 3000 is FXX.
相关临床试验
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相关器械（代码：FXX）
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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