FDA 510(k)

清潔針筒（預充0.9%生理鹽水溶液）

K 號：K231724 · 2023-11-09

決定日期2023-11-09

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

Flush Syringe (Prefilled 0.9% normal saline solution) is the device name listed in this FDA 510(k) record. The listed applicant is Spm Medicare Pvt. , Ltd.. It received FDA 510(k) clearance on 2023-11-09 under 510(k) number K231724. 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 Flush Syringe (Prefilled 0.9% normal saline solution)?

Flush Syringe (Prefilled 0.9% normal saline solution) is a medical device that received FDA 510(k) clearance on 2023-11-09. The listed applicant is Spm Medicare Pvt. , Ltd.. The 510(k) number is K231724.

When did Flush Syringe (Prefilled 0.9% normal saline solution) receive FDA 510(k) clearance?

Flush Syringe (Prefilled 0.9% normal saline solution) received FDA 510(k) clearance on 2023-11-09, under 510(k) number K231724.

Who is the listed applicant for Flush Syringe (Prefilled 0.9% normal saline solution)?

The FDA 510(k) record lists Spm Medicare Pvt. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Flush Syringe (Prefilled 0.9% normal saline solution)?

The FDA product code for Flush Syringe (Prefilled 0.9% normal saline solution) is NGT.

其他以 Spm Medicare Pvt. , Ltd. 為申請人之記錄

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K233794胰島素針筒

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.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.K230756TK預充生理鹼注射器Anhui Tiankang Medical Technology Co., Ltd.K223584預充生理鹼注射器Anhui Tianyang Pharmaceutical Co., Ltd.K2311610.9% 钠鹽注射劑，USP BD PosiFlush™ SF 輸液針筒Becton, Dickinson and Company

官方來源

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