FDA product code LMY: Monitor, Skin Resistance/Skin Temperature, For Insulin Reactions
LMY is the FDA product code for monitor, skin resistance/skin temperature, for insulin reactions. It is a Class III device, reviewed by the Clinical Chemistry panel. Devices under LMY reach the market by PMA; FDA lists no cleared 510(k)s for it. 1 PMA application cites this product code.
Classification
| Field | Value |
|---|---|
| Device name | Monitor, Skin Resistance/Skin Temperature, For Insulin Reactions |
| Device class | Class III |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for LMY devices
openFDA lists no recalls for product code LMY.
Frequently asked questions
What is FDA product code LMY?
LMY is the FDA product code for monitor, skin resistance/skin temperature, for insulin reactions. It is a Class III device, reviewed by the Clinical Chemistry panel.
What device class is LMY?
Class III. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code LMY
- Run a recall and safety report across every LMY manufacturer
- Watch product code LMY 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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