FDA 510(k)

德爾塔韻快閃閉式靜脈留置針系統

K 號：K200373 · 2020-08-26

決定日期2020-08-26

產品代碼FOZ

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

Deltaven Fast Flash Closed I.V. Catheter Systems is the device name listed in this FDA 510(k) record. The listed applicant is Delta Med Spa. It received FDA 510(k) clearance on 2020-08-26 under 510(k) number K200373. The device is classified under product code FOZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Deltaven Fast Flash Closed I.V. Catheter Systems?

Deltaven Fast Flash Closed I.V. Catheter Systems is a medical device that received FDA 510(k) clearance on 2020-08-26. The listed applicant is Delta Med Spa. The 510(k) number is K200373.

When did Deltaven Fast Flash Closed I.V. Catheter Systems receive FDA 510(k) clearance?

Deltaven Fast Flash Closed I.V. Catheter Systems received FDA 510(k) clearance on 2020-08-26, under 510(k) number K200373.

Who is the listed applicant for Deltaven Fast Flash Closed I.V. Catheter Systems?

The FDA 510(k) record lists Delta Med Spa as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Deltaven Fast Flash Closed I.V. Catheter Systems?

The FDA product code for Deltaven Fast Flash Closed I.V. Catheter Systems is FOZ.

其他以 Delta Med Spa 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。

K171530Deltaven XiV Max, Deltaven XiV Max FF

相關器械（代碼：FOZ）

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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