HEO
- Product code
- HEO
- Device name
- Analyzer, Data, Obstetric
- Device class
- Class 3
- 21 CFR
- 21 CFR 884.2050
- Medical specialty
- Obstetrics/Gynecology
- Marketing pathway
- PMA
FDA classification definition
Call for PMAs to be filed by 10/3/00 per 65 FR 41332 on 7/5/00
Official FDA classification page: HEO
Classification and pathway per current FDA publications. Data from openFDA (CC0).