FDA product code HHX: Holograph, Fetal, Acoustical
HHX is the FDA product code for holograph, fetal, acoustical. It is a Class II device, regulated under 21 CFR 884.2225 and reviewed by the Obstetrics and Gynecology panel. Devices under HHX reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Holograph, Fetal, Acoustical |
| Device class | Class II |
| Regulation | 21 CFR 884.2225 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Recalls for HHX devices
openFDA lists no recalls for product code HHX.
Frequently asked questions
What is FDA product code HHX?
HHX is the FDA product code for holograph, fetal, acoustical. It is a Class II device, regulated under 21 CFR 884.2225 and reviewed by the Obstetrics and Gynecology panel.
What device class is HHX?
Class II, regulation 21 CFR 884.2225. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code HHX
- Run a recall and safety report across every HHX manufacturer
- Watch product code HHX 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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