FDA 510(k)

一次性血壓袖帶；可重複使用血壓袖帶

K 號：K242623 · 2024-10-31

決定日期2024-10-31

產品代碼DXQ

諮詢委員會履歷

決定相當於

器材摘要

Disposable Blood Pressure cuff; Reusable Blood Pressure cuff is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Medke Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-10-31 under 510(k) number K242623. 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 Disposable Blood Pressure cuff; Reusable Blood Pressure cuff?

Disposable Blood Pressure cuff; Reusable Blood Pressure cuff is a medical device that received FDA 510(k) clearance on 2024-10-31. The listed applicant is Shenzhen Medke Technology Co., Ltd.. The 510(k) number is K242623.

When did Disposable Blood Pressure cuff; Reusable Blood Pressure cuff receive FDA 510(k) clearance?

Disposable Blood Pressure cuff; Reusable Blood Pressure cuff received FDA 510(k) clearance on 2024-10-31, under 510(k) number K242623.

Who is the listed applicant for Disposable Blood Pressure cuff; Reusable Blood Pressure cuff?

The FDA 510(k) record lists Shenzhen Medke Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable Blood Pressure cuff; Reusable Blood Pressure cuff?

The FDA product code for Disposable Blood Pressure cuff; Reusable Blood Pressure cuff is DXQ.

其他以 Shenzhen Medke Technology Co., Ltd. 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。

K243000可重用溫度探針（T1306、T2306、T3306、T4306）；一次性溫度探針（T5106、T6106）K152390Medke 輸氧量手指感測器

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 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

官方來源

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