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QNYNot classified

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

Unknown
FDA source (opens on fda.gov)

QNY is the FDA product code for Remote Or Wearable Patient Monitoring Device For Drug Induced Qt Prolongation Monitoring. FDA's definition for this code reads: "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...". As of , FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code
QNY
Device name
Remote Or Wearable Patient Monitoring Device For Drug Induced Qt Prolongation Monitoring
FDA 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.
Device class
Not classified
Review panel
Unknown
Submission type
FDA code 8
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
0

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code QNY.