FDA 510(k)

使い捨て自動リトラクタブルインスリン安全性注射器

K番号: K210216 · 2022-03-04

申請者Shantou Wealy Medical Instrument Co.,Ltd

決定日2022-03-04

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

Disposable Automatically Retractable Insulin Safety Syringe is the device name listed in this FDA 510(k) record. The listed applicant is Shantou Wealy Medical Instrument Co.,Ltd. It received FDA 510(k) clearance on 2022-03-04 under 510(k) number K210216. 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 Disposable Automatically Retractable Insulin Safety Syringe?

Disposable Automatically Retractable Insulin Safety Syringe is a medical device that received FDA 510(k) clearance on 2022-03-04. The listed applicant is Shantou Wealy Medical Instrument Co.,Ltd. The 510(k) number is K210216.

When did Disposable Automatically Retractable Insulin Safety Syringe receive FDA 510(k) clearance?

Disposable Automatically Retractable Insulin Safety Syringe received FDA 510(k) clearance on 2022-03-04, under 510(k) number K210216.

Who is the listed applicant for Disposable Automatically Retractable Insulin Safety Syringe?

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

What is the FDA product code for Disposable Automatically Retractable Insulin Safety Syringe?

The FDA product code for Disposable Automatically Retractable Insulin Safety Syringe is MEG.

申請者としてShantou Wealy Medical Instrument Co.,Ltdを記載するその他の記録

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