FDA product code MRK: System, Imaging, Fluorescence
MRK is the FDA product code for system, imaging, fluorescence. It is a Class III device, reviewed by the Ear, Nose and Throat panel. Devices under MRK reach the market by PMA; FDA lists no cleared 510(k)s for it. 2 PMA applications cite this product code.
Classification
| Field | Value |
|---|---|
| Device name | System, Imaging, Fluorescence |
| Device class | Class III |
| Review panel | EN — Ear, Nose and Throat |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for MRK devices
openFDA lists no recalls for product code MRK.
Frequently asked questions
What is FDA product code MRK?
MRK is the FDA product code for system, imaging, fluorescence. It is a Class III device, reviewed by the Ear, Nose and Throat panel.
What device class is MRK?
Class III. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code MRK
- Run a recall and safety report across every MRK manufacturer
- Watch product code MRK 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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