PMA P020001
- Device
- STAN S31 FETAL HEART MONITOR
- Applicant
- Neoventa Medical AB
- PMA number
- P020001
- Supplement
- S009
- Product code
- HEO
- Decision date
- 2011-11-18
- Generic name
- Analyzer, data, obstetric
- Approval order statement
- APPROVAL FOR THE ADDITION OF AN ACCESSORY, THE STAN VIEWER LIVE, WHICH ALLOWS REMOTE VIEWING OF AN ONGOING STAN S31 RECORDING.
Current openFDA PMA Record#
- Device
- STAN S31 FETAL HEART MONITOR
- Applicant
- Neoventa Medical AB
- PMA number
- P020001
- Supplement
- S009
- Product code
- HEO
- Generic name
- Analyzer, data, obstetric
- Decision date
- 2011-11-18
- Decision code
- APPR
- Date received
- 2011-09-21
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE ADDITION OF AN ACCESSORY, THE STAN VIEWER LIVE, WHICH ALLOWS REMOTE VIEWING OF AN ONGOING STAN S31 RECORDING.