FDA product code JON: Transducer, Apex Cardiographic
JON is the FDA product code for transducer, apex cardiographic. It is a Class II device, regulated under 21 CFR 870.2840 and reviewed by the Cardiovascular panel. Devices under JON reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Transducer, Apex Cardiographic |
| Device class | Class II |
| Regulation | 21 CFR 870.2840 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Recalls for JON devices
openFDA lists no recalls for product code JON.
Frequently asked questions
What is FDA product code JON?
JON is the FDA product code for transducer, apex cardiographic. It is a Class II device, regulated under 21 CFR 870.2840 and reviewed by the Cardiovascular panel.
What device class is JON?
Class II, regulation 21 CFR 870.2840. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code JON
- Run a recall and safety report across every JON manufacturer
- Watch product code JON 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.