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U.S. Department of Health and Human Services

Product Classification
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Device remote or wearable patient monitoring device for drug induced qt prolongation monitoring
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.
Physical State n/a
Technical Method n/a
Target Area n/a
Review Panel Cardiovascular
Product CodeQNY
Premarket Review Office of Cardiovascular Devices (OHT2)
Cardiac Electrophysiology, Diagnostics, and Monitoring Devices (DHT2A)
Not Classified Reason EUA - Emergency Use Authorization
Submission Type EUA - Emergency Use Authorization
Device Class Not Classified
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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