FDA 510(k)

單次使用无菌皮下注射針筒

K 號：K213811 · 2022-05-12

決定日期2022-05-12

產品代碼FMF

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

Sterile Hypodermic Syringes for Single Use is the device name listed in this FDA 510(k) record. The listed applicant is Berpu Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-05-12 under 510(k) number K213811. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Sterile Hypodermic Syringes for Single Use?

Sterile Hypodermic Syringes for Single Use is a medical device that received FDA 510(k) clearance on 2022-05-12. The listed applicant is Berpu Medical Technology Co., Ltd.. The 510(k) number is K213811.

When did Sterile Hypodermic Syringes for Single Use receive FDA 510(k) clearance?

Sterile Hypodermic Syringes for Single Use received FDA 510(k) clearance on 2022-05-12, under 510(k) number K213811.

Who is the listed applicant for Sterile Hypodermic Syringes for Single Use?

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

What is the FDA product code for Sterile Hypodermic Syringes for Single Use?

The FDA product code for Sterile Hypodermic Syringes for Single Use is FMF.

其他以 Berpu Medical Technology Co., Ltd. 為申請人之記錄

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。

K232165單次使用无菌針筒針；單次使用无菌針筒針- 可棄針筒針；單次使用无菌針筒針- 自封針筒針 K221045無針胰島素針筒 K220061安全胰島素針筒 K213158針筒式注射器 K212514單次使用安全針筒針，胰島素針筒針 K181447單次使用安全胰島素針

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相關器械（代碼：FMF）

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。

K262581GraftGun 適用性移植輸送系統 (GDS®)SurGenTec, LLC K252184SOL-M 輪狀釋放針筒配可交換針盤Sol-Millennium Medical, Inc.K253747一次性針筒注射器（KXYC-03C02，KXYC-03A03）Jiangsu Enjosim Medical Technology Co., Ltd.K260208超細™ 安全胰島素針embecta Medical II, LLC K253110溶滑安全針；溶滑安全針搭配針筒Sol-Millennium Medical, Inc.K260514Profoject™ 安全針；Profoject™ 配有安全針的注射器；Profoject™ 低死腔配有安全針的注射器CMT Health PTE., Ltd.

官方來源

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