FDA 510(k)

Insulin Syringe, Insulin Syringe with Safety Retractable

K番号: K202570 · 2021-07-02

申請者Jiangsu Micsafe Medical Technology Co., Ltd.

決定日2021-07-02

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Substantially Equivalent

医療機器の概要

Insulin Syringe, Insulin Syringe with Safety Retractable is the device name listed in this FDA 510(k) record. The listed applicant is Jiangsu Micsafe Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-07-02 under 510(k) number K202570. 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 Insulin Syringe, Insulin Syringe with Safety Retractable?

Insulin Syringe, Insulin Syringe with Safety Retractable is a medical device that received FDA 510(k) clearance on 2021-07-02. The listed applicant is Jiangsu Micsafe Medical Technology Co., Ltd.. The 510(k) number is K202570.

When did Insulin Syringe, Insulin Syringe with Safety Retractable receive FDA 510(k) clearance?

Insulin Syringe, Insulin Syringe with Safety Retractable received FDA 510(k) clearance on 2021-07-02, under 510(k) number K202570.

Who is the listed applicant for Insulin Syringe, Insulin Syringe with Safety Retractable?

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

What is the FDA product code for Insulin Syringe, Insulin Syringe with Safety Retractable?

The FDA product code for Insulin Syringe, Insulin Syringe with Safety Retractable is MEG.

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