FDA 510(k)

U&U Indicator tape and strip

K番号: K171823 · 2018-02-22

決定日2018-02-22

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Substantially Equivalent

医療機器の概要

U&U Indicator tape and strip is the device name listed in this FDA 510(k) record. The listed applicant is U&U Medical Technology Co, Ltd.. It received FDA 510(k) clearance on 2018-02-22 under 510(k) number K171823. 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 U&U Indicator tape and strip?

U&U Indicator tape and strip is a medical device that received FDA 510(k) clearance on 2018-02-22. The listed applicant is U&U Medical Technology Co, Ltd.. The 510(k) number is K171823.

When did U&U Indicator tape and strip receive FDA 510(k) clearance?

U&U Indicator tape and strip received FDA 510(k) clearance on 2018-02-22, under 510(k) number K171823.

Who is the listed applicant for U&U Indicator tape and strip?

The FDA 510(k) record lists U&U Medical Technology Co, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for U&U Indicator tape and strip?

The FDA product code for U&U Indicator tape and strip is JOJ.

申請者としてU&U Medical Technology Co, Ltd.を記載するその他の記録

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