心檢 心跳 ECG 監護器 配 GEMS 行動式

HeartCheck Cardi Beat ECG Monitor with GEMS Mobile is the device name listed in this FDA 510(k) record. The listed applicant is Cardiocomm Solutions, Inc.. It received FDA 510(k) clearance on 2019-02-22 under 510(k) number K181310. The device is classified under product code DXH. It was reviewed by the CV advisory panel. Product code DXH falls under the category of Hematology, which includes devices for blood cell counting, coagulation testing, and hemoglobin analysis. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.