PADnet Xpress
K 號：K220527 · 2022-10-20
廣告
器材摘要
PADnet Xpress is the device name listed in this FDA 510(k) record. The listed applicant is Collaborative Care Diagnostics, LLC, D.B.A. Biomedix. It received FDA 510(k) clearance on 2022-10-20 under 510(k) number K220527. The device is classified under product code JOM. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the PADnet Xpress?
PADnet Xpress is a medical device that received FDA 510(k) clearance on 2022-10-20. The listed applicant is Collaborative Care Diagnostics, LLC, D.B.A. Biomedix. The 510(k) number is K220527.
When did PADnet Xpress receive FDA 510(k) clearance?
PADnet Xpress received FDA 510(k) clearance on 2022-10-20, under 510(k) number K220527.
Who is the listed applicant for PADnet Xpress?
The FDA 510(k) record lists Collaborative Care Diagnostics, LLC, D.B.A. Biomedix as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for PADnet Xpress?
The FDA product code for PADnet Xpress is JOM.
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。
相關器械（代碼：JOM）
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。
K213730MESI mTABLET TBI 腦震傷診斷系統，MESI mTABLET TBIMesi, Development of Medical Devices, Ltd.; Mesi D.O.O.K200567ASI 肺活量測定儀Arterial Stiffness, Inc.K201046自動踝壓脈壓指數測量設備，MESI mTABLET 系統Mesi D.O.O.; Mesi, Development of Medical Devices, Ltd.K191266VitalScan ANSMedeia, Inc.K172655自動踝壓脈壓指數測量設備Mesi D.O.O.; Mesi, Development of Medical Devices, Ltd.K173696TBL-ABI 系統Ld Technology, LLC
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。
廣告