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FDA 510(k)

DASH 6 NRFit Lock 静脈注射針筒 + 適用品，DASH 6 NRFit 滑動針筒 + 適用品，DASH 6 NRFit 塑膠 LOR 針筒 + 適用品

K 號：K170900 · 2017-11-09

申請人Intervene Group, Ltd.
決定日期2017-11-09
產品代碼FMF
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

DASH 6 NRFit Lock Syringe + Accessories, DASH 6 NRFit Slip Syringe + Accessories, DASH 6 NRFit Plastic LOR Syringe + Accessories is the device name listed in this FDA 510(k) record. The listed applicant is Intervene Group, Ltd.. It received FDA 510(k) clearance on 2017-11-09 under 510(k) number K170900. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the DASH 6 NRFit Lock Syringe + Accessories, DASH 6 NRFit Slip Syringe + Accessories, DASH 6 NRFit Plastic LOR Syringe + Accessories?

DASH 6 NRFit Lock Syringe + Accessories, DASH 6 NRFit Slip Syringe + Accessories, DASH 6 NRFit Plastic LOR Syringe + Accessories is a medical device that received FDA 510(k) clearance on 2017-11-09. The listed applicant is Intervene Group, Ltd.. The 510(k) number is K170900.

When did DASH 6 NRFit Lock Syringe + Accessories, DASH 6 NRFit Slip Syringe + Accessories, DASH 6 NRFit Plastic LOR Syringe + Accessories receive FDA 510(k) clearance?

DASH 6 NRFit Lock Syringe + Accessories, DASH 6 NRFit Slip Syringe + Accessories, DASH 6 NRFit Plastic LOR Syringe + Accessories received FDA 510(k) clearance on 2017-11-09, under 510(k) number K170900.

Who is the listed applicant for DASH 6 NRFit Lock Syringe + Accessories, DASH 6 NRFit Slip Syringe + Accessories, DASH 6 NRFit Plastic LOR Syringe + Accessories?

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

What is the FDA product code for DASH 6 NRFit Lock Syringe + Accessories, DASH 6 NRFit Slip Syringe + Accessories, DASH 6 NRFit Plastic LOR Syringe + Accessories?

The FDA product code for DASH 6 NRFit Lock Syringe + Accessories, DASH 6 NRFit Slip Syringe + Accessories, DASH 6 NRFit Plastic LOR Syringe + Accessories is FMF.

相關臨床試驗

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：FMF）

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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