FDA 510(k)

YP-710T系列無創血壓袖帶；YP-840T系列一次性袖帶

K 號：K260747 · 2026-05-06

決定日期2026-05-06

產品代碼DXQ

諮詢委員會履歷

決定相當於

器材摘要

YP-710T Series NIBP Cuff;YP-840T Series Disposable Cuff is the device name listed in this FDA 510(k) record. The listed applicant is Nihon Kohden Corporation. It received FDA 510(k) clearance on 2026-05-06 under 510(k) number K260747. The device is classified under product code DXQ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the YP-710T Series NIBP Cuff;YP-840T Series Disposable Cuff?

YP-710T Series NIBP Cuff;YP-840T Series Disposable Cuff is a medical device that received FDA 510(k) clearance on 2026-05-06. The listed applicant is Nihon Kohden Corporation. The 510(k) number is K260747.

When did YP-710T Series NIBP Cuff;YP-840T Series Disposable Cuff receive FDA 510(k) clearance?

YP-710T Series NIBP Cuff;YP-840T Series Disposable Cuff received FDA 510(k) clearance on 2026-05-06, under 510(k) number K260747.

Who is the listed applicant for YP-710T Series NIBP Cuff;YP-840T Series Disposable Cuff?

FDA 510(k) 記錄中將 Nihon Kohden Corporation 列為申請人。這並不單獨確立設備製造商的身份。

What is the FDA product code for YP-710T Series NIBP Cuff;YP-840T Series Disposable Cuff?

The FDA product code for YP-710T Series NIBP Cuff;YP-840T Series Disposable Cuff is DXQ.

其他以 Nihon Kohden Corporation 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：DXQ）

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。

K254287Medline可重用血壓袖帶Medline Industries, LP K253089NIBP 腕帶 (BCS-112, BCS-212, BCS-312, BCS-412, BCS-512, BCS-612, BCS-712, BCS-122, BCS-222, BCS-322, BCS-422, BCS-522, BCS-622, BCS-722, BCD-112, BCD-212, BCD-312, BCD-412, BCD-512, BCD-612, BCD-712, BCD-122, BCD-222, BCD-322, BCD-422, BCD-522, BCD-622, BCD-722)Shenzhen Best Electronics Co., Ltd.K253964可抛弃式新生兒NIBP袖帶 (U1681S-C51N)Unimed Medical Supplies, Inc.K251745威爾奇艾倫 FlexiPort 血壓袖帶（FlexiPort 血壓袖帶）Baxter Healthcare Corporation K250765AViTA手臂型血壓監測器袖帶Avita Corporation K251045可棄用新生兒NIBP袖帶（U1682S-C51N）；可棄用新生兒NIBP袖帶（U1683S-C51N）；可棄用新生兒NIBP袖帶（U1684S-C51N）；可棄用新生兒NIBP袖帶（U1685S-C51N）Unimed Medical Supplies, Inc.

官方來源

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