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FDA 510(k)

SimpleSense-BP, SimpleSense-BP 軟體應用程序

K 號：K232053 · 2023-12-08

申請人Nanowear, Inc.
決定日期2023-12-08
產品代碼DXN
諮詢委員會履歷
決定相當於

器材摘要

SimpleSense-BP, SimpleSense-BP Software Application is the device name listed in this FDA 510(k) record. The listed applicant is Nanowear, Inc.. It received FDA 510(k) clearance on 2023-12-08 under 510(k) number K232053. The device is classified under product code DXN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the SimpleSense-BP, SimpleSense-BP Software Application?

SimpleSense-BP, SimpleSense-BP Software Application is a medical device that received FDA 510(k) clearance on 2023-12-08. The listed applicant is Nanowear, Inc.. The 510(k) number is K232053.

When did SimpleSense-BP, SimpleSense-BP Software Application receive FDA 510(k) clearance?

SimpleSense-BP, SimpleSense-BP Software Application received FDA 510(k) clearance on 2023-12-08, under 510(k) number K232053.

Who is the listed applicant for SimpleSense-BP, SimpleSense-BP Software Application?

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

What is the FDA product code for SimpleSense-BP, SimpleSense-BP Software Application?

The FDA product code for SimpleSense-BP, SimpleSense-BP Software Application is DXN.

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 Nanowear, Inc. 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。

K212160SimpleSENSE 平台K201669簡單感應器K161431簡易心電圖

相關器械（代碼：DXN）

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。

K261929上臂血壓監測器（BP7155D）OMRON Healthcare, Inc.K254000快樂健康血壓監測器Happy Health, Inc.K262658自動數位血壓監測器（LD-526）Honsun (Nantong) Co., Ltd.K261394臂式全自動數字血壓計（DBP-6186 Plus、DBP-6286B Plus、DBP-61E3 Plus、DBP-61E2 Plus、DBP-62E3B Plus、DBP-62E2B Plus）JOYTECH Healthcare Co., Ltd.K253425臂式全自动數字血壓監測儀（DBP-6194-P,DBP-6294B-P,DBP-6195P,DBP-6295B-P, DBP-6196P,DBP-6296B-P,DBP-61E1-P, DBP-62E1B-P,DBP-62E3B-P,DBP-61E2-P,DBP-62E2B-P,DBP-61E3-P,DBP-6173-P,DBP-6273B-P,DBP-6179-P,DBP-6279B-P）Joytech Healthcare Co. , Ltd.K261061BP Go (BPP-855)Wellvii, Inc.

官方來源

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