FDA 510(k)

血液量分析儀（200）

K 號：K261099 · 2026-06-18

決定日期2026-06-18

產品代碼JWO

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

Blood Volume Analyzer (200) is the device name listed in this FDA 510(k) record. The listed applicant is Daxor Corporation. It received FDA 510(k) clearance on 2026-06-18 under 510(k) number K261099. The device is classified under product code JWO. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Blood Volume Analyzer (200)?

Blood Volume Analyzer (200) is a medical device that received FDA 510(k) clearance on 2026-06-18. The listed applicant is Daxor Corporation. The 510(k) number is K261099.

When did Blood Volume Analyzer (200) receive FDA 510(k) clearance?

Blood Volume Analyzer (200) received FDA 510(k) clearance on 2026-06-18, under 510(k) number K261099.

Who is the listed applicant for Blood Volume Analyzer (200)?

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

What is the FDA product code for Blood Volume Analyzer (200)?

The FDA product code for Blood Volume Analyzer (200) is JWO.

其他以 Daxor Corporation 為申請人之記錄

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K251087血液量分析儀（200）

相關器械（代碼：JWO）

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。

K251087血液量分析儀（200）Daxor Corporation

官方來源

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