FDA product code QLJ: Patient Monitor With Independent Remote Display And Operation
QLJ is the FDA product code for patient monitor with independent remote display and operation. It is a Not classified device, reviewed by the Cardiovascular panel. Devices under QLJ reach the market by PMA; FDA lists no cleared 510(k)s for it.
Definition
Monitors intended for the remote display and operation of patient physiological monitors, including alarm functionality, signal analysis, and data recording during declared public health emergency.
Classification
| Field | Value |
|---|---|
| Device name | Patient Monitor With Independent Remote Display And Operation |
| Device class | Not classified |
| Review panel | CV — Cardiovascular |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for QLJ devices
openFDA lists no recalls for product code QLJ.
Frequently asked questions
What is FDA product code QLJ?
QLJ is the FDA product code for patient monitor with independent remote display and operation. It is a Not classified device, reviewed by the Cardiovascular panel.
What device class is QLJ?
Not classified. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code QLJ
- Run a recall and safety report across every QLJ manufacturer
- Watch product code QLJ 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.