FDA product code MLN: Electrode, Electrocardiograph, Multi-Function
MLN is the FDA product code for electrode, electrocardiograph, multi-function. It is a Class II device, regulated under 21 CFR 870.2360 and reviewed by the Cardiovascular panel. Devices under MLN reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it. FDA has posted 9 recalls for MLN devices.
Classification
| Field | Value |
|---|---|
| Device name | Electrode, Electrocardiograph, Multi-Function |
| Device class | Class II |
| Regulation | 21 CFR 870.2360 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) exempt |
Recalls for MLN devices
9 product recalls in 6 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2011-03-31.
Frequently asked questions
What is FDA product code MLN?
MLN is the FDA product code for electrode, electrocardiograph, multi-function. It is a Class II device, regulated under 21 CFR 870.2360 and reviewed by the Cardiovascular panel.
What device class is MLN?
Class II, regulation 21 CFR 870.2360. Typical premarket route: 510(k) exempt.
Have MLN devices been recalled?
Yes: 9 product recalls across 6 recall events; the most recent began 2011-03-31.
Next steps
- Run an FDA pathway report with predicate devices for product code MLN
- Run a recall and safety report across every MLN manufacturer
- Watch product code MLN 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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