FDA 510(k)

Accutension Smartphone Auscultatory Blood

K 號：K180335 · 2018-03-08

決定日期2018-03-08

產品代碼DXQ

諮詢委員會履歷

決定相當於

器材摘要

Accutension Smartphone Auscultatory Blood is the device name listed in this FDA 510(k) record. The listed applicant is Shanghai Hulu Devices Co., Ltd.. It received FDA 510(k) clearance on 2018-03-08 under 510(k) number K180335. 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 Accutension Smartphone Auscultatory Blood?

Accutension Smartphone Auscultatory Blood is a medical device that received FDA 510(k) clearance on 2018-03-08. The listed applicant is Shanghai Hulu Devices Co., Ltd.. The 510(k) number is K180335.

When did Accutension Smartphone Auscultatory Blood receive FDA 510(k) clearance?

Accutension Smartphone Auscultatory Blood received FDA 510(k) clearance on 2018-03-08, under 510(k) number K180335.

Who is the listed applicant for Accutension Smartphone Auscultatory Blood?

FDA 510(k) 記錄將上海漢魯設備有限公司列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Accutension Smartphone Auscultatory Blood?

The FDA product code for Accutension Smartphone Auscultatory Blood is DXQ.

其他以 Shanghai Hulu Devices 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。

K261494智慧無線聽診器（STEMO310）；智慧無線聽診器（STEMO710）；智慧無線聽診器（STEMO720）；智慧無線聽診器（STEMO730）K220470智慧無線聽診器

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

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。