FDA 510(k)

TEVADAPTOR 閉じ込め薬剤再構成および移送システム

K番号: K180489 · 2018-09-21

決定日2018-09-21

製品コードONB

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

TEVADAPTOR Closed Drug Reconstitution and Transfer System is the device name listed in this FDA 510(k) record. The listed applicant is Teva Medical Ltd., Migada Plant. It received FDA 510(k) clearance on 2018-09-21 under 510(k) number K180489. The device is classified under product code ONB. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the TEVADAPTOR Closed Drug Reconstitution and Transfer System?

TEVADAPTOR Closed Drug Reconstitution and Transfer System is a medical device that received FDA 510(k) clearance on 2018-09-21. The listed applicant is Teva Medical Ltd., Migada Plant. The 510(k) number is K180489.

When did TEVADAPTOR Closed Drug Reconstitution and Transfer System receive FDA 510(k) clearance?

TEVADAPTOR Closed Drug Reconstitution and Transfer System received FDA 510(k) clearance on 2018-09-21, under 510(k) number K180489.

Who is the listed applicant for TEVADAPTOR Closed Drug Reconstitution and Transfer System?

The FDA 510(k) record lists Teva Medical Ltd., Migada Plant as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TEVADAPTOR Closed Drug Reconstitution and Transfer System?

The FDA product code for TEVADAPTOR Closed Drug Reconstitution and Transfer System is ONB.

申請者としてTeva Medical Ltd., Migada Plantを記載するその他の記録

K170680TEVADAPTOR 閉じ込め薬剤再構成および移送システム

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