FDA 510(k)

AMSafe 預充生理鹽水注射器

K 號：K213522 · 2022-03-22

決定日期2022-03-22

產品代碼NGT

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

AMSafe Pre-Filled Normal Saline Flush Syringe is the device name listed in this FDA 510(k) record. The listed applicant is Amsino International, Inc.. It received FDA 510(k) clearance on 2022-03-22 under 510(k) number K213522. The device is classified under product code NGT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the AMSafe Pre-Filled Normal Saline Flush Syringe?

AMSafe Pre-Filled Normal Saline Flush Syringe is a medical device that received FDA 510(k) clearance on 2022-03-22. The listed applicant is Amsino International, Inc.. The 510(k) number is K213522.

When did AMSafe Pre-Filled Normal Saline Flush Syringe receive FDA 510(k) clearance?

AMSafe Pre-Filled Normal Saline Flush Syringe received FDA 510(k) clearance on 2022-03-22, under 510(k) number K213522.

Who is the listed applicant for AMSafe Pre-Filled Normal Saline Flush Syringe?

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

What is the FDA product code for AMSafe Pre-Filled Normal Saline Flush Syringe?

The FDA product code for AMSafe Pre-Filled Normal Saline Flush Syringe is NGT.

其他以 Amsino International, Inc. 為申請人之記錄

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K252543AMSafe 藥物輸注套件 (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, BA-70072-F, BA-70071-DF, BA-70071-DF-120, FE01, FE04)K220230AMSure 胃內輸食泵 K220267AMSafe 非針頭連接器 K200051PUGGLE 飲食輸送泵及輸送組 K183473AMSafe(R) 預充生理鹽水注射器 K181445AMSure 湿性間歇性導尿管

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相關器械（代碼：NGT）

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。

K2508840.9 % 钠鹽注射劑，USP，BD PosiFlush™ SP 静脈注射針Becton, Dickinson and Company K233623Praxiject™ SP 0.9% 食鹽水Medxl, Inc.K231724清潔針筒（預充0.9%生理鹽水溶液）Spm Medicare Pvt. , Ltd.K231363漢德科技預充0.9%生理鹼注射器（型號PFS-1003、PFS-1005、PFS-1010）Hantech Medical Device Co., Ltd.K223584預充生理鹼注射器Anhui Tianyang Pharmaceutical Co., Ltd.K230756TK預充生理鹼注射器Anhui Tiankang Medical Technology Co., Ltd.

官方來源

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