FDA 510(k)

單次使用无菌針筒（含/不含針）

K 號：K211211 · 2021-10-07

決定日期2021-10-07

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 syringes for single use with/without needle is the device name listed in this FDA 510(k) record. The listed applicant is Azur Medical Company, Inc.. It received FDA 510(k) clearance on 2021-10-07 under 510(k) number K211211. 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 syringes for single use with/without needle?

Sterile syringes for single use with/without needle is a medical device that received FDA 510(k) clearance on 2021-10-07. The listed applicant is Azur Medical Company, Inc.. The 510(k) number is K211211.

When did Sterile syringes for single use with/without needle receive FDA 510(k) clearance?

Sterile syringes for single use with/without needle received FDA 510(k) clearance on 2021-10-07, under 510(k) number K211211.

Who is the listed applicant for Sterile syringes for single use with/without needle?

The FDA 510(k) record lists Azur Medical Company, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sterile syringes for single use with/without needle?

The FDA product code for Sterile syringes for single use with/without needle is FMF.

其他以 Azur Medical Company, Inc. 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。

K231719醫療外科口罩 K211210无菌單次使用自閉針筒（含/不含針）K211214單次使用无菌皮下針頭

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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