FDA 510(k)

Praxiject™ 0.9% NaCl

K 號：K231754 · 2023-07-13

決定日期2023-07-13

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

Praxiject™ 0.9% NaCl is the device name listed in this FDA 510(k) record. The listed applicant is Medxl, Inc.. It received FDA 510(k) clearance on 2023-07-13 under 510(k) number K231754. 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 Praxiject™ 0.9% NaCl?

Praxiject™ 0.9% NaCl is a medical device that received FDA 510(k) clearance on 2023-07-13. The listed applicant is Medxl, Inc.. The 510(k) number is K231754.

When did Praxiject™ 0.9% NaCl receive FDA 510(k) clearance?

Praxiject™ 0.9% NaCl received FDA 510(k) clearance on 2023-07-13, under 510(k) number K231754.

Who is the listed applicant for Praxiject™ 0.9% NaCl?

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

What is the FDA product code for Praxiject™ 0.9% NaCl?

The FDA product code for Praxiject™ 0.9% NaCl is NGT.

其他以 Medxl, 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。

K233623Praxiject™ SP 0.9% 食鹽水 K192414Praxiject 0.9% NaCl K171109Praxiject 0.9% NaCl

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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