← FDA Medical Device Classifications
Analyzer, Data, Obstetric
HEO · Class III — High Risk (PMA approval required, life-sustaining) · Obstetrics/Gynecology · 21 CFR 884.2050
Classification
- FDA Product Code
HEO- Device class
- Class III — High Risk (PMA approval required, life-sustaining)
- Regulation
- 21 CFR 884.2050
- Review panel
- OB
- Medical specialty
- Obstetrics/Gynecology
- Submission type
- 2
- GMP exempt
- N
- Life sustaining
- N
- Implant
- N
- Third-party review
- N
Definition
Call for PMAs to be filed by 10/3/00 per 65 FR 41332 on 7/5/00
Market data
- Cleared 510(k) submissions
- 0
- Registered establishments
- 0
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown