NEOVENTA'S STAN S31 FETAL HEART MONITOR
FDA premarket approval P020001/S008 · decided 2011-08-04
Approval details
- PMA number
- P020001
- Supplement
- S008
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- NEOVENTA'S STAN S31 FETAL HEART MONITOR
- Generic name
- Analyzer, data, obstetric
- Applicant
- Neoventa Medical AB
- Date received
- 2011-07-07
- Decision date
- 2011-08-04
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- HEO
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Molndal
- Statement
- ADDITION OF AN INSPECTION TEST FOR THE DEVICE.
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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 |