Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | 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 | S009 |
Date Received | 09/21/2011 |
Decision Date | 11/18/2011 |
Product Code |
HEO |
Advisory Committee |
Obstetrics/Gynecology |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE ADDITION OF AN ACCESSORY, THE STAN VIEWER LIVE, WHICH ALLOWS REMOTE VIEWING OF AN ONGOING STAN S31 RECORDING. |
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