FDA product code QNY: Remote Or Wearable Patient Monitoring Device For Drug Induced Qt Prolongation Monitoring
QNY is the FDA product code for remote or wearable patient monitoring device for drug induced qt prolongation monitoring. It is a Not classified device, reviewed by the Cardiovascular panel. Devices under QNY reach the market by PMA; FDA lists no cleared 510(k)s for it.
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.
Classification
| Field | Value |
|---|---|
| Device name | Remote Or Wearable Patient Monitoring Device For Drug Induced Qt Prolongation Monitoring |
| Device class | Not classified |
| Review panel | CV — Cardiovascular |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for QNY devices
openFDA lists no recalls for product code QNY.
Frequently asked questions
What is FDA product code QNY?
QNY is the FDA product code for remote or wearable patient monitoring device for drug induced qt prolongation monitoring. It is a Not classified device, reviewed by the Cardiovascular panel.
What device class is QNY?
Not classified. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code QNY
- Run a recall and safety report across every QNY manufacturer
- Watch product code QNY for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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