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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameSTAN S31 FETAL HEART MONITOR
Classification Nameanalyzer, data, obstetric
Generic Nameobstetric data analyzer
Regulation Number884.2050
ApplicantNEOVENTA MEDICAL AB
PMA NumberP020001
Supplement NumberS009
Date Received09/21/2011
Decision Date11/18/2011
Product Code
HEO[ Registered Establishments with HEO ]
Advisory Committee Obstetrics/Gynecology
Supplement Typereal-time process
Supplement Reason change design/components/specifications - software
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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