FDA product code HEO: Analyzer, Data, Obstetric
HEO is the FDA product code for analyzer, data, obstetric. It is a Class III device, regulated under 21 CFR 884.2050 and reviewed by the Obstetrics and Gynecology panel. Devices under HEO reach the market by PMA; FDA lists no cleared 510(k)s for it. 1 PMA application cites this product code.
Definition
Call for PMAs to be filed by 10/3/00 per 65 FR 41332 on 7/5/00
Classification
| Field | Value |
|---|---|
| Device name | Analyzer, Data, Obstetric |
| Device class | Class III |
| Regulation | 21 CFR 884.2050 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | PMA |
Recalls for HEO devices
openFDA lists no recalls for product code HEO.
Frequently asked questions
What is FDA product code HEO?
HEO is the FDA product code for analyzer, data, obstetric. It is a Class III device, regulated under 21 CFR 884.2050 and reviewed by the Obstetrics and Gynecology panel.
What device class is HEO?
Class III, regulation 21 CFR 884.2050. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code HEO
- Run a recall and safety report across every HEO manufacturer
- Watch product code HEO 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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