FDA product code HGO: Monitor, Electroencephalographic, Fetal (And Accessories)
HGO is the FDA product code for monitor, electroencephalographic, fetal (and accessories). It is a Class III device, regulated under 21 CFR 884.2620 and reviewed by the Obstetrics and Gynecology panel. Devices under HGO reach the market by PMA; FDA lists no cleared 510(k)s for it.
Definition
Call for PMAs to be filed by 12/26/96 per 61 FR 50708 on 9/27/96
Classification
| Field | Value |
|---|---|
| Device name | Monitor, Electroencephalographic, Fetal (And Accessories) |
| Device class | Class III |
| Regulation | 21 CFR 884.2620 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | PMA |
Recalls for HGO devices
openFDA lists no recalls for product code HGO.
Frequently asked questions
What is FDA product code HGO?
HGO is the FDA product code for monitor, electroencephalographic, fetal (and accessories). It is a Class III device, regulated under 21 CFR 884.2620 and reviewed by the Obstetrics and Gynecology panel.
What device class is HGO?
Class III, regulation 21 CFR 884.2620. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code HGO
- Run a recall and safety report across every HGO manufacturer
- Watch product code HGO 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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