FDA 510(k)

Quantra 體內止血分析儀

K 號：K232215 · 2023-08-24

決定日期2023-08-24

產品代碼QFR

諮詢委員會HE 請提供完整的描述文本，以便我能夠進行翻譯。

決定相當於

器材摘要

Quantra Hemostasis Analyzer is the device name listed in this FDA 510(k) record. The listed applicant is Hemosonics, LLC. It received FDA 510(k) clearance on 2023-08-24 under 510(k) number K232215. The device is classified under product code QFR. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Quantra Hemostasis Analyzer?

Quantra Hemostasis Analyzer is a medical device that received FDA 510(k) clearance on 2023-08-24. The listed applicant is Hemosonics, LLC. The 510(k) number is K232215.

When did Quantra Hemostasis Analyzer receive FDA 510(k) clearance?

Quantra Hemostasis Analyzer received FDA 510(k) clearance on 2023-08-24, under 510(k) number K232215.

Who is the listed applicant for Quantra Hemostasis Analyzer?

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

What is the FDA product code for Quantra Hemostasis Analyzer?

The FDA product code for Quantra Hemostasis Analyzer is QFR.

其他以 Hemosonics, LLC 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。

K251404Quantra QStat 製劑 K240045QStat 製劑 K230461Quantra 體內止血分析儀 K223433Quantra QPlus 系統 K213917QStat 製劑 K201513Quantra QPlus 系統

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相關器械（代碼：QFR）

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。

K251404Quantra QStat 製劑Hemosonics, LLC K240045QStat 製劑Hemosonics, LLC K230461Quantra 體內止血分析儀Hemosonics, LLC K223433Quantra QPlus 系統Hemosonics, LLC K213917QStat 製劑Hemosonics, LLC K201513Quantra QPlus 系統Hemosonics, LLC

官方來源

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