FDA product code HEJ: Monitor, Hemic Sound, Ultrasonic
HEJ is the FDA product code for monitor, hemic sound, ultrasonic. It is a Class II device, regulated under 21 CFR 884.2660 and reviewed by the Obstetrics and Gynecology panel. Devices under HEJ reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Monitor, Hemic Sound, Ultrasonic |
| Device class | Class II |
| Regulation | 21 CFR 884.2660 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Recalls for HEJ devices
openFDA lists no recalls for product code HEJ.
Frequently asked questions
What is FDA product code HEJ?
HEJ is the FDA product code for monitor, hemic sound, ultrasonic. It is a Class II device, regulated under 21 CFR 884.2660 and reviewed by the Obstetrics and Gynecology panel.
What device class is HEJ?
Class II, regulation 21 CFR 884.2660. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code HEJ
- Run a recall and safety report across every HEJ manufacturer
- Watch product code HEJ 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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