FDA product code OCH: Oximeter, Infrared, Sporting, Aviation
OCH is the FDA product code for oximeter, infrared, sporting, aviation. It is a Class II device, regulated under 21 CFR 870.2700 and reviewed by the Cardiovascular panel. Devices under OCH reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Definition
Solely for use with sporting and aviation activities. Intended to monitor heart rate during exercise.
Classification
| Field | Value |
|---|---|
| Device name | Oximeter, Infrared, Sporting, Aviation |
| Device class | Class II |
| Regulation | 21 CFR 870.2700 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) exempt |
Recalls for OCH devices
openFDA lists no recalls for product code OCH.
Frequently asked questions
What is FDA product code OCH?
OCH is the FDA product code for oximeter, infrared, sporting, aviation. It is a Class II device, regulated under 21 CFR 870.2700 and reviewed by the Cardiovascular panel.
What device class is OCH?
Class II, regulation 21 CFR 870.2700. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code OCH
- Run a recall and safety report across every OCH manufacturer
- Watch product code OCH 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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