FDA 510(k)

Medline可重用血壓袖帶

K 號：K254287 · 2026-06-22

決定日期2026-06-22

產品代碼DXQ

諮詢委員會履歷

決定相當於

器材摘要

Medline Reusable Blood Pressure Cuff is the device name listed in this FDA 510(k) record. The listed applicant is Medline Industries, LP. It received FDA 510(k) clearance on 2026-06-22 under 510(k) number K254287. 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 Medline Reusable Blood Pressure Cuff?

Medline Reusable Blood Pressure Cuff is a medical device that received FDA 510(k) clearance on 2026-06-22. The listed applicant is Medline Industries, LP. The 510(k) number is K254287.

When did Medline Reusable Blood Pressure Cuff receive FDA 510(k) clearance?

Medline Reusable Blood Pressure Cuff received FDA 510(k) clearance on 2026-06-22, under 510(k) number K254287.

Who is the listed applicant for Medline Reusable Blood Pressure Cuff?

FDA 510(k) 記錄中將 Medline Industries, LP 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Medline Reusable Blood Pressure Cuff?

The FDA product code for Medline Reusable Blood Pressure Cuff is DXQ.

其他以 Medline Industries, LP 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。

K253526NAMIC 扩張器及套管 K253322Hudson RCI®嬰兒乾燥技術TM呼吸回路 (HUD99060 / 乾燥技術配78英寸嬰兒回路，HUD99060KIT / 乾燥技術配78英寸嬰兒回路套件，HUD99001KIT / 单臂嬰兒回路乾燥技術套件，HUD99009KIT / 乾燥技術配60英寸嬰兒回路套件，HUD99018KIT / 乾燥技術配44英寸嬰兒回路套件，HUD870NKIT / 乾燥技術嬰兒配件袋，HUD1631 / 嬰兒Y型接頭配轉動環)K251687康尼格貝爾環切夾 K253070Namic 放射臂帶，23 公分（DYNJRADBAND）；Namic 放射臂帶，26 公分（DYNJRADBANDL）K250345美林袋式分酒器 K250312Hudson RCI® 舒適流鼻管預產期、嬰兒；Hudson RCI® 舒適流 Plus 及軟 Plus 鼻管超小號

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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。

K260747YP-710T系列無創血壓袖帶；YP-840T系列一次性袖帶Nihon Kohden Corporation 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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