FDA 510(k)

TK預充生理鹼注射器

K 號：K230756 · 2023-08-12

申請人Anhui Tiankang Medical Technology Co., Ltd.

決定日期2023-08-12

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

TK Pre-Filled Normal Saline Flush Syringe is the device name listed in this FDA 510(k) record. The listed applicant is Anhui Tiankang Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-08-12 under 510(k) number K230756. 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 TK Pre-Filled Normal Saline Flush Syringe?

TK Pre-Filled Normal Saline Flush Syringe is a medical device that received FDA 510(k) clearance on 2023-08-12. The listed applicant is Anhui Tiankang Medical Technology Co., Ltd.. The 510(k) number is K230756.

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

TK Pre-Filled Normal Saline Flush Syringe received FDA 510(k) clearance on 2023-08-12, under 510(k) number K230756.

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

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

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

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

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

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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.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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