FDA 510(k)

SafeR注射器およびSafeRスティング

K番号: K221981 · 2022-12-29

決定日2022-12-29

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

SafeR Syringe and SafeR Sting is the device name listed in this FDA 510(k) record. The listed applicant is Roncadelle Operations Srl. It received FDA 510(k) clearance on 2022-12-29 under 510(k) number K221981. 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 SafeR Syringe and SafeR Sting?

SafeR Syringe and SafeR Sting is a medical device that received FDA 510(k) clearance on 2022-12-29. The listed applicant is Roncadelle Operations Srl. The 510(k) number is K221981.

When did SafeR Syringe and SafeR Sting receive FDA 510(k) clearance?

SafeR Syringe and SafeR Sting received FDA 510(k) clearance on 2022-12-29, under 510(k) number K221981.

Who is the listed applicant for SafeR Syringe and SafeR Sting?

The FDA 510(k) record lists Roncadelle Operations Srl as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SafeR Syringe and SafeR Sting?

The FDA product code for SafeR Syringe and SafeR Sting is MEG.

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SafeR注射器およびSafeRスティング

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：MEG）

公式ソース