通用智慧心電圖
K 號：K173952 · 2018-08-28
廣告
器材摘要
Universal SmartECG is the device name listed in this FDA 510(k) record. The listed applicant is Vectracor, Inc.. It received FDA 510(k) clearance on 2018-08-28 under 510(k) number K173952. The device is classified under product code DPS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Universal SmartECG?
Universal SmartECG is a medical device that received FDA 510(k) clearance on 2018-08-28. The listed applicant is Vectracor, Inc.. The 510(k) number is K173952.
When did Universal SmartECG receive FDA 510(k) clearance?
Universal SmartECG received FDA 510(k) clearance on 2018-08-28, under 510(k) number K173952.
Who is the listed applicant for Universal SmartECG?
The FDA 510(k) record lists Vectracor, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Universal SmartECG?
The FDA product code for Universal SmartECG is DPS.
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：DPS）
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。
K254255S-Patch 心臟AIWellysis Corp.K252463SE-1202系列心電圖儀（型號：SE-1202，SE-1202E）Edan Instruments, Inc.K251670MAC 7 靜息心電圖分析系統Ge Medical Systems Information Technologies, Inc.K252361AccurECG Analysis System (v2.0)Accurkardia, Inc.K252474Withings BeamO (SCT02)WithingsK250569Cardiologs 霍爾特平台Philips France Commercial
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