FDA 510(k)

PowerPAK 靜脈注射針

K 號：K220114 · 2023-01-25

決定日期2023-01-25

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

PowerPAK Syringe is the device name listed in this FDA 510(k) record. The listed applicant is Vault Paragon Group, Inc.. It received FDA 510(k) clearance on 2023-01-25 under 510(k) number K220114. 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 PowerPAK Syringe?

PowerPAK Syringe is a medical device that received FDA 510(k) clearance on 2023-01-25. The listed applicant is Vault Paragon Group, Inc.. The 510(k) number is K220114.

When did PowerPAK Syringe receive FDA 510(k) clearance?

PowerPAK Syringe received FDA 510(k) clearance on 2023-01-25, under 510(k) number K220114.

Who is the listed applicant for PowerPAK Syringe?

The FDA 510(k) record lists Vault Paragon Group, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PowerPAK Syringe?

The FDA product code for PowerPAK Syringe is MEG.

其他以 Vault Paragon Group, Inc. 為申請人之記錄

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K250847霧盾

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 Corporation K231907美林安全胰島素及結核針筒Medline Industries, LP K223376Monoject 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

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