FDA 510(k)

FEELject LDV（低死腔）針筒

K 號：K213010 · 2023-05-31

決定日期2023-05-31

產品代碼QNQ

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

FEELject LDV (Low dead volume) syringe is the device name listed in this FDA 510(k) record. The listed applicant is Feeltech Co., Ltd.. It received FDA 510(k) clearance on 2023-05-31 under 510(k) number K213010. The device is classified under product code QNQ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the FEELject LDV (Low dead volume) syringe?

FEELject LDV (Low dead volume) syringe is a medical device that received FDA 510(k) clearance on 2023-05-31. The listed applicant is Feeltech Co., Ltd.. The 510(k) number is K213010.

When did FEELject LDV (Low dead volume) syringe receive FDA 510(k) clearance?

FEELject LDV (Low dead volume) syringe received FDA 510(k) clearance on 2023-05-31, under 510(k) number K213010.

Who is the listed applicant for FEELject LDV (Low dead volume) syringe?

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

What is the FDA product code for FEELject LDV (Low dead volume) syringe?

The FDA product code for FEELject LDV (Low dead volume) syringe is QNQ.

其他以 Feeltech Co., Ltd. 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。

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相關器械（代碼：QNQ）

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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