FDA 510(k)

PuraStat

K号: K222481 · 2023-02-28

决定日期2023-02-28

产品代码QAU

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决定实质等同

器械摘要

PuraStat is the device name listed in this FDA 510(k) record. The listed applicant is 3-D Matrix, Inc.. It received FDA 510(k) clearance on 2023-02-28 under 510(k) number K222481. The device is classified under product code QAU. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the PuraStat?

PuraStat is a medical device that received FDA 510(k) clearance on 2023-02-28. The listed applicant is 3-D Matrix, Inc.. The 510(k) number is K222481.

When did PuraStat receive FDA 510(k) clearance?

PuraStat received FDA 510(k) clearance on 2023-02-28, under 510(k) number K222481.

Who is the listed applicant for PuraStat?

FDA 510(k)记录显示3-D Matrix，Inc.为申请人。这本身并不能确立该设备制造商的身份。

What is the FDA product code for PuraStat?

The FDA product code for PuraStat is QAU.

列明3-D Matrix, Inc.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。

K261503PuraStat 胃肠 K261504PuraStat-RM K213552PuraStat-RM K210211PuraStat-OM K210098PuraStat-GI K193085PuraDERM凝胶

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官方来源

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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。