FDA 510(k)

充気バルブ付きシリンジアダプタ転送装置 - 13mm

K番号: K160503 · 2016-05-04

決定日2016-05-04

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

Vented Vial Adapter Transfer Device - 13mm is the device name listed in this FDA 510(k) record. The listed applicant is Medimop Medical Projects, Ltd.. It received FDA 510(k) clearance on 2016-05-04 under 510(k) number K160503. 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 Vented Vial Adapter Transfer Device - 13mm?

Vented Vial Adapter Transfer Device - 13mm is a medical device that received FDA 510(k) clearance on 2016-05-04. The listed applicant is Medimop Medical Projects, Ltd.. The 510(k) number is K160503.

When did Vented Vial Adapter Transfer Device - 13mm receive FDA 510(k) clearance?

Vented Vial Adapter Transfer Device - 13mm received FDA 510(k) clearance on 2016-05-04, under 510(k) number K160503.

Who is the listed applicant for Vented Vial Adapter Transfer Device - 13mm?

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

What is the FDA product code for Vented Vial Adapter Transfer Device - 13mm?

The FDA product code for Vented Vial Adapter Transfer Device - 13mm is LHI.

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充気バルブ付きシリンジアダプタ転送装置 - 13mm

医療機器の概要

よくある質問

関連する臨床試験

関連機器（コード：LHI）

公式ソース