FDA 510(k)

MixJect® 転送装置

K番号: K230464 · 2023-05-22

決定日2023-05-22

製品コードLHI

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

MixJect® Transfer Device is the device name listed in this FDA 510(k) record. The listed applicant is West Pharma. Services IL, Ltd.. It received FDA 510(k) clearance on 2023-05-22 under 510(k) number K230464. The device is classified under product code LHI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the MixJect® Transfer Device?

MixJect® Transfer Device is a medical device that received FDA 510(k) clearance on 2023-05-22. The listed applicant is West Pharma. Services IL, Ltd.. The 510(k) number is K230464.

When did MixJect® Transfer Device receive FDA 510(k) clearance?

MixJect® Transfer Device received FDA 510(k) clearance on 2023-05-22, under 510(k) number K230464.

Who is the listed applicant for MixJect® Transfer Device?

The FDA 510(k) record lists West Pharma. Services IL, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MixJect® Transfer Device?

The FDA product code for MixJect® Transfer Device is LHI.

申請者としてWest Pharma. Services IL, Ltd.を記載するその他の記録

K231071Mix2Vial® 転送装置 K232875Vial Adapter 20mm K230988Vial2Bag Advanced® 13mm Admixture Device K213513Vented Vial Adapter 20mm

公式ソース

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