FDA 510(k)

Acuity SDR Standard、Acuity SDR Plus、Acuity FDR Standard

K番号: K193360 · 2020-01-02

決定日2020-01-02

製品コードKPR

諮問委員会RA （注：由于原文中未提供具体的医疗设备监管文本内容，因此无法进行翻译。请提供具体的文本内容以便进行翻译。）

決定大幅同等

医療機器の概要

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.

よくある質問

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.

申請者としてRadmedix, LLCを記載するその他の記録

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

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