FDA 510(k)

Acuity SDR 标准型，Acuity SDR Plus，Acuity FDR 标准型

K号: K193360 · 2020-01-02

决定日期2020-01-02

产品代码KPR

咨询委员会RA

决定实质等同

器械摘要

Acuity SDR Standard, Acuity SDR Plus, Acuity FDR Standard is the device name listed in this FDA 510(k) record. The listed applicant is Radmedix, LLC. It received FDA 510(k) clearance on 2020-01-02 under 510(k) number K193360. The device is classified under product code KPR. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Acuity SDR Standard, Acuity SDR Plus, Acuity FDR Standard?

Acuity SDR Standard, Acuity SDR Plus, Acuity FDR Standard is a medical device that received FDA 510(k) clearance on 2020-01-02. The listed applicant is Radmedix, LLC. The 510(k) number is K193360.

When did Acuity SDR Standard, Acuity SDR Plus, Acuity FDR Standard receive FDA 510(k) clearance?

Acuity SDR Standard, Acuity SDR Plus, Acuity FDR Standard received FDA 510(k) clearance on 2020-01-02, under 510(k) number K193360.

Who is the listed applicant for Acuity SDR Standard, Acuity SDR Plus, Acuity FDR Standard?

The FDA 510(k) record lists Radmedix, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Acuity SDR Standard, Acuity SDR Plus, Acuity FDR Standard?

The FDA product code for Acuity SDR Standard, Acuity SDR Plus, Acuity FDR Standard is KPR.

列明Radmedix, LLC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。

K231995AcuityUDR K231709AcuityDR 1013 G4，AcuityDR 1417 G4，AcuityDR 1717G4 K210919AcuityDRe K201058Accuvue+K200726AcuityPDR

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。