Product code HEO
- Device name
- Analyzer, Data, Obstetric
- Medical specialty
- Obstetrics/Gynecology
- Device class
- 3
- Regulation number
- 884.2050
- Review panel
- OB
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Definition
- Call for PMAs to be filed by 10/3/00 per 65 FR 41332 on 7/5/00
- Source
- FDA openFDA device classification dataset