FDA product code HFP: Monitor, Phonocardiographic, Fetal
HFP is the FDA product code for monitor, phonocardiographic, fetal. It is a Class II device, regulated under 21 CFR 884.2640 and reviewed by the Obstetrics and Gynecology panel. Devices under HFP reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Monitor, Phonocardiographic, Fetal |
| Device class | Class II |
| Regulation | 21 CFR 884.2640 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Recalls for HFP devices
openFDA lists no recalls for product code HFP.
Frequently asked questions
What is FDA product code HFP?
HFP is the FDA product code for monitor, phonocardiographic, fetal. It is a Class II device, regulated under 21 CFR 884.2640 and reviewed by the Obstetrics and Gynecology panel.
What device class is HFP?
Class II, regulation 21 CFR 884.2640. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code HFP
- Run a recall and safety report across every HFP manufacturer
- Watch product code HFP 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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