|
Device | NEOVENTA'S STAN S31 FETAL HEART MONITOR |
Generic Name | Analyzer, data, obstetric |
Regulation Number | 884.2050 |
Applicant | NEOVENTA MEDICAL AB NORRA AGATAN 32 SE-431 35 MOLNDAL |
PMA Number | P020001 |
Supplement Number | S008 |
Date Received | 07/07/2011 |
Decision Date | 08/04/2011 |
Product Code |
HEO |
Advisory Committee |
Obstetrics/Gynecology |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement ADDITION OF AN INSPECTION TEST FOR THE DEVICE. |