免責聲明: 本站彙整 FDA、ClinicalTrials.gov、PubMed、SEC EDGAR 等官方公開資料，僅供一般參考，不構成醫療建議、診斷、治療建議或投資建議。

FDA 510(k)

NanoPress 760A-BT (760A-BT)

K 號：K254267 · 2026-02-24

申請人Mego Afek , Ltd.
決定日期2026-02-24
產品代碼JOW
諮詢委員會履歷
決定相當於

器材摘要

NanoPress 760A-BT (760A-BT) is the device name listed in this FDA 510(k) record. The listed applicant is Mego Afek , Ltd.. It received FDA 510(k) clearance on 2026-02-24 under 510(k) number K254267. The device is classified under product code JOW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the NanoPress 760A-BT (760A-BT)?

NanoPress 760A-BT (760A-BT) is a medical device that received FDA 510(k) clearance on 2026-02-24. The listed applicant is Mego Afek , Ltd.. The 510(k) number is K254267.

When did NanoPress 760A-BT (760A-BT) receive FDA 510(k) clearance?

NanoPress 760A-BT (760A-BT) received FDA 510(k) clearance on 2026-02-24, under 510(k) number K254267.

Who is the listed applicant for NanoPress 760A-BT (760A-BT)?

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

What is the FDA product code for NanoPress 760A-BT (760A-BT)?

The FDA product code for NanoPress 760A-BT (760A-BT) is JOW.

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

相關器械（代碼：JOW）

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。

K261807連續循環器（SC-4004-DL，SC-4008-DL）Bio Compression Systems, Inc.K254217AerloomEvolym, LLCK253555Flexitouch® Plus 進階氣動壓迫系統Tactile MedicalK253386DVT 裝備Vistar Medical Supplies Co., Ltd.K250242壓力治療設備（LGT-2202DVT）Guangzhou Longest Medical Technology Co., Ltd.K250974生物動脈豪華版（IC-BAP-DX）Bio Compression Systems, Inc.

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。

↑