PMA P020001S008
- Device
- NEOVENTA'S STAN S31 FETAL HEART MONITOR
- Applicant
- Neoventa Medical AB
- PMA number
- P020001
- Supplement
- S008
- Product code
- HEO
- Decision date
- 2011-08-04
- Generic name
- Analyzer, data, obstetric
- Approval order statement
- ADDITION OF AN INSPECTION TEST FOR THE DEVICE.
Current openFDA PMA Record#
- Device
- NEOVENTA'S STAN S31 FETAL HEART MONITOR
- Applicant
- Neoventa Medical AB
- PMA number
- P020001
- Supplement
- S008
- Product code
- HEO
- Generic name
- Analyzer, data, obstetric
- Decision date
- 2011-08-04
- Decision code
- OK30
- Date received
- 2011-07-07
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ADDITION OF AN INSPECTION TEST FOR THE DEVICE.