量化心電圖檢測器（QED 2000）
K 號：K152135 · 2016-08-09
廣告
器材摘要
Quantitative Electrocardiographic Detector (QED 2000) is the device name listed in this FDA 510(k) record. The listed applicant is Acme Portable Machines, Inc.. It received FDA 510(k) clearance on 2016-08-09 under 510(k) number K152135. 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 Quantitative Electrocardiographic Detector (QED 2000)?
Quantitative Electrocardiographic Detector (QED 2000) is a medical device that received FDA 510(k) clearance on 2016-08-09. The listed applicant is Acme Portable Machines, Inc.. The 510(k) number is K152135.
When did Quantitative Electrocardiographic Detector (QED 2000) receive FDA 510(k) clearance?
Quantitative Electrocardiographic Detector (QED 2000) received FDA 510(k) clearance on 2016-08-09, under 510(k) number K152135.
Who is the listed applicant for Quantitative Electrocardiographic Detector (QED 2000)?
The FDA 510(k) record lists Acme Portable Machines, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Quantitative Electrocardiographic Detector (QED 2000)?
The FDA product code for Quantitative Electrocardiographic Detector (QED 2000) 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