FDA 510(k)

無菌注射器および安全針（単回使用）、無菌注射器（単回使用）、無菌安全針（単回使用）

K番号: K192679 · 2020-04-10

決定日2020-04-10

製品コードMEG

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

Sterile Syringe with Safety needle for Single Use, Sterile Syringe for Single Use, Sterile Safety Needle for Single Use is the device name listed in this FDA 510(k) record. The listed applicant is Gemtier Medical (Shanghai), Inc.. It received FDA 510(k) clearance on 2020-04-10 under 510(k) number K192679. The device is classified under product code MEG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Sterile Syringe with Safety needle for Single Use, Sterile Syringe for Single Use, Sterile Safety Needle for Single Use?

Sterile Syringe with Safety needle for Single Use, Sterile Syringe for Single Use, Sterile Safety Needle for Single Use is a medical device that received FDA 510(k) clearance on 2020-04-10. The listed applicant is Gemtier Medical (Shanghai), Inc.. The 510(k) number is K192679.

When did Sterile Syringe with Safety needle for Single Use, Sterile Syringe for Single Use, Sterile Safety Needle for Single Use receive FDA 510(k) clearance?

Sterile Syringe with Safety needle for Single Use, Sterile Syringe for Single Use, Sterile Safety Needle for Single Use received FDA 510(k) clearance on 2020-04-10, under 510(k) number K192679.

Who is the listed applicant for Sterile Syringe with Safety needle for Single Use, Sterile Syringe for Single Use, Sterile Safety Needle for Single Use?

The FDA 510(k) record lists Gemtier Medical (Shanghai), Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sterile Syringe with Safety needle for Single Use, Sterile Syringe for Single Use, Sterile Safety Needle for Single Use?

The FDA product code for Sterile Syringe with Safety needle for Single Use, Sterile Syringe for Single Use, Sterile Safety Needle for Single Use is MEG.

申請者としてGemtier Medical (Shanghai), Inc.を記載するその他の記録

K212652無菌注射器および固定安全針付き単回使用注射器 K202493医療用フェイスマスク K202331医療用フェイスマスク K170276単回使用用の安全性血液採取装置

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