FDA 510(k)

WAVICIDE-OPA MEC インディケーター

K番号: K202565 · 2020-12-02

決定日2020-12-02

製品コードJOJ

諮問委員会医療機器規制テキストの翻訳は以下の通りです。 HO [翻訳が提供されなかったため、原文の「HO」がそのまま使用されます]

決定大幅同等

医療機器の概要

WAVICIDE-OPA MEC Indicator is the device name listed in this FDA 510(k) record. The listed applicant is Serim Research Corporation. It received FDA 510(k) clearance on 2020-12-02 under 510(k) number K202565. The device is classified under product code JOJ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the WAVICIDE-OPA MEC Indicator?

WAVICIDE-OPA MEC Indicator is a medical device that received FDA 510(k) clearance on 2020-12-02. The listed applicant is Serim Research Corporation. The 510(k) number is K202565.

When did WAVICIDE-OPA MEC Indicator receive FDA 510(k) clearance?

WAVICIDE-OPA MEC Indicator received FDA 510(k) clearance on 2020-12-02, under 510(k) number K202565.

Who is the listed applicant for WAVICIDE-OPA MEC Indicator?

The FDA 510(k) record lists Serim Research Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for WAVICIDE-OPA MEC Indicator?

The FDA product code for WAVICIDE-OPA MEC Indicator is JOJ.

申請者としてSerim Research Corporationを記載するその他の記録

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