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FDA 510(k)

AViTA手臂型血壓監測器袖帶

K 號：K250765 · 2025-09-03

申請人Avita Corporation
決定日期2025-09-03
產品代碼DXQ
諮詢委員會履歷
決定相當於

器材摘要

AViTA Arm Type Blood Pressure Monitor Cuff is the device name listed in this FDA 510(k) record. The listed applicant is Avita Corporation. It received FDA 510(k) clearance on 2025-09-03 under 510(k) number K250765. 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 AViTA Arm Type Blood Pressure Monitor Cuff?

AViTA Arm Type Blood Pressure Monitor Cuff is a medical device that received FDA 510(k) clearance on 2025-09-03. The listed applicant is Avita Corporation. The 510(k) number is K250765.

When did AViTA Arm Type Blood Pressure Monitor Cuff receive FDA 510(k) clearance?

AViTA Arm Type Blood Pressure Monitor Cuff received FDA 510(k) clearance on 2025-09-03, under 510(k) number K250765.

Who is the listed applicant for AViTA Arm Type Blood Pressure Monitor Cuff?

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

What is the FDA product code for AViTA Arm Type Blood Pressure Monitor Cuff?

The FDA product code for AViTA Arm Type Blood Pressure Monitor Cuff is DXQ.

相關臨床試驗

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

其他以 Avita 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。

K250129AViTA乳泵K252448AViTA脉搏血氧儀 (SP61)K242455AViTA 脉搏血氧計 (SP62B)K241852鼻吸器（NS 13）K242193手臂型血壓監測器 (BPM82)K223399AViTA脉搏血氧儀

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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, LPK260747YP-710T系列無創血壓袖帶；YP-840T系列一次性袖帶Nihon Kohden CorporationK253089NIBP 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 CorporationK251045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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