FDA product code QNY

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

Unknown·Class N·21 CFR
US regulatory classifications
US Product Code (FDA)
QNY
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US Risk Class (FDA)
Class N
US Regulation (CFR)
21 CFR
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Medical specialty
Unknown
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
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.

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Remote Or Wearable Patient Monitoring Device For Drug Induced Qt Prolongation Monitoring is a medical device type in the Unknown specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.