安全注射器及安全注射針
K 號：K221981 · 2022-12-29
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決定日期2022-12-29
產品代碼MEG
諮詢委員會醫療設備規範文本翻譯如下：
HO
注意：原文中未提供具體的醫療設備規範文本，因此上述翻譯僅為示例。請提供完整的規範文本以便進行準確翻譯。
決定相當於
器材摘要
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.
常見問題
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.
相關臨床試驗
相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。
相關器械（代碼：MEG）
相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。
K252098PA3X可拆式安全套筒針筒（含針）（SC-23ED / SD-23ED）Methyl Co., Ltd.K250847霧盾Vault Paragon Group, Inc.K230287SaviSafe 安全設備Suzhou Savicred Biotechnology Co., Ltd.K231165信娜針筒；信娜安全針筒Shina Med CorporationK231907美林安全胰島素及結核針筒Medline Industries, LPK223376Monoject Magellan 胰島素安全針筒 1mL, 31G x 6mm (8881893110)；Monoject Magellan 胰島素安全針筒 0.5mL, 31G x 6mm (8881893150)；Monoject Magellan 胰島素安全針筒 0.3mL, 31G x 6mm (8881893130)Cardinal Health200, LLC
官方來源
在 FDA 資料庫中查看 →資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。
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