QNY

Remote Or Wearable Patient Monitoring Device For Drug Induced Qt Prolongation Monitoring

Product code

QNY

Device name

Remote Or Wearable Patient Monitoring Device For Drug Induced Qt Prolongation Monitoring

Device class

Class N

Medical specialty

Unknown

Marketing pathway

EUA - Emergency Use Authorization

FDA classification definition

To be used by healthcare professionals (HCP) in the hospital setting for remote monitoring and detection of changes in the QT interval of an electrocardiogram (ECG) in general care patients who are 18 years of age or older and are undergoing treatment with drugs that can prolong QT intervals and may cause life threatening arrhythmias. Device used during declared public health emergency.

Definition text from the FDA device classification database (U.S. federal government work, public domain).