QNY — Remote Or Wearable Patient Monitoring Device For Drug Induced Qt Prolongation Monitoring Class N
FDA product code QNY covers "Remote Or Wearable Patient Monitoring Device For Drug Induced Qt Prolongation Monitoring", a Class N medical device. Submissions are reviewed by the Unknown panel.
Classification Details
- Product Code
- QNY
- Device Class
- Class N
- Regulation Number
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Unknown
- Implant
- No
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.