PMA P020001S001
- Device
- STAN S31 FETAL HEART MONITOR
- Applicant
- Neoventa Medical AB
- PMA number
- P020001
- Supplement
- S001
- Product code
- HEO
- Decision date
- 2007-07-03
- Generic name
- Analyzer, data, obstetric
- Approval order statement
- REDESIGN OF THE WIRING ARRANGEMENT WITHIN THE TRANSDUCER COMPONENT OF THE SYSTEM.
Current openFDA PMA Record#
- Device
- STAN S31 FETAL HEART MONITOR
- Applicant
- Neoventa Medical AB
- PMA number
- P020001
- Supplement
- S001
- Product code
- HEO
- Generic name
- Analyzer, data, obstetric
- Decision date
- 2007-07-03
- Decision code
- OK30
- Date received
- 2007-06-04
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- REDESIGN OF THE WIRING ARRANGEMENT WITHIN THE TRANSDUCER COMPONENT OF THE SYSTEM.