STAN S31 FETAL HEART MONITOR
FDA premarket approval P020001 · decided 2005-11-01
Approval details
- PMA number
- P020001
- Trade name
- STAN S31 FETAL HEART MONITOR
- Generic name
- Analyzer, data, obstetric
- Applicant
- Neoventa Medical AB
- Date received
- 2002-01-02
- Decision date
- 2005-11-01
- Days to decision
- 1399 days
- Decision code
- APPR
- Product code
- HEO
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Molndal
- Statement
- APPROVAL FOR THE STAN S31 FETAL HEART MONITOR. THE DEVICE IS INDICATED AS AN ADJUNCT TO FETAL HEART RATE MONITORING TO DETERMINE WHETHER OBSTETRICAL INTERVENTION IS WARRANTED WHEN THERE IS INCREASED RISK OF DEVELOPING METABOLIC ACIDOSIS. THE DEVICE IS INTENDED FOR USE IN PATIENTS WITH: 1) PLANNED VAGINAL DELIVERY; 2) >36 COMPLETED WEEKS GESTATION; 3) SINGLETON FETUS; 4) VERTEX PRESENTATION; AND 5) RUPTURED AMNIOTIC MEMBRANES.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Goldtrace Fetal Spiral Electrode (FSE) (CNS000004) (K243291) | Neoventa Medical AB | 2025-01-17 |