STAN S31 SYSTEM
FDA premarket approval P020001/S007 · decided 2010-02-01
Approval details
- PMA number
- P020001
- Supplement
- S007
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- STAN S31 SYSTEM
- Generic name
- Analyzer, data, obstetric
- Applicant
- Neoventa Medical AB
- Date received
- 2009-07-23
- Decision date
- 2010-02-01
- Days to decision
- 193 days
- Decision code
- APPR
- Product code
- HEO
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Molndal
- Statement
- APPROVAL FOR VARIOUS HARDWARE, SOFTWARE, AND LABELING UPGRADES INCLUDINGINTEGRATION OF MATERNAL NON-INVASIVE BLOOD PRESSURE AND OXYGEN SATURATION MONITORING ANDALARMS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME STAN S31 AND ISINDICATED FOR:MONITORING OF FETUS AND MOTHER THROUGHOUT LABOR AND DELIVERY. THE FOLLOWING PARAMETERSCAN BE MONITORED WITH STAN S31: 1) FETAL HEART RATE; 2) FETAL ECG WAVEFORM; 3) UTERINE ACTIVITY; 4) MATERNAL NON-INVASIVE BLOOD PRESSURE; 5) MATERNAL SPO2
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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 |