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FDA 510(k)

0.9% 钠鹽靜脈注射用針筒，1 支/包，0.9% 钠鹽靜脈注射用針筒，2 支/包

K 號：K201286 · 2020-08-11

申請人Nurse Assist, LLC
決定日期2020-08-11
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

0.9% Sodium Chloride I.V. Flush Syringe for Sterile Delivery, 1 syringe/pouch, 0.9% Sodium Chloride I.V. Flush Syringe for Sterile Delivery, 2 syringes/pouch is the device name listed in this FDA 510(k) record. The listed applicant is Nurse Assist, LLC. It received FDA 510(k) clearance on 2020-08-11 under 510(k) number K201286. 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 0.9% Sodium Chloride I.V. Flush Syringe for Sterile Delivery, 1 syringe/pouch, 0.9% Sodium Chloride I.V. Flush Syringe for Sterile Delivery, 2 syringes/pouch?

0.9% Sodium Chloride I.V. Flush Syringe for Sterile Delivery, 1 syringe/pouch, 0.9% Sodium Chloride I.V. Flush Syringe for Sterile Delivery, 2 syringes/pouch is a medical device that received FDA 510(k) clearance on 2020-08-11. The listed applicant is Nurse Assist, LLC. The 510(k) number is K201286.

When did 0.9% Sodium Chloride I.V. Flush Syringe for Sterile Delivery, 1 syringe/pouch, 0.9% Sodium Chloride I.V. Flush Syringe for Sterile Delivery, 2 syringes/pouch receive FDA 510(k) clearance?

0.9% Sodium Chloride I.V. Flush Syringe for Sterile Delivery, 1 syringe/pouch, 0.9% Sodium Chloride I.V. Flush Syringe for Sterile Delivery, 2 syringes/pouch received FDA 510(k) clearance on 2020-08-11, under 510(k) number K201286.

Who is the listed applicant for 0.9% Sodium Chloride I.V. Flush Syringe for Sterile Delivery, 1 syringe/pouch, 0.9% Sodium Chloride I.V. Flush Syringe for Sterile Delivery, 2 syringes/pouch?

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

What is the FDA product code for 0.9% Sodium Chloride I.V. Flush Syringe for Sterile Delivery, 1 syringe/pouch, 0.9% Sodium Chloride I.V. Flush Syringe for Sterile Delivery, 2 syringes/pouch?

The FDA product code for 0.9% Sodium Chloride I.V. Flush Syringe for Sterile Delivery, 1 syringe/pouch, 0.9% Sodium Chloride I.V. Flush Syringe for Sterile Delivery, 2 syringes/pouch is NGT.

相關臨床試驗

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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。

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官方來源

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