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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 NumberS005
Date Received02/06/2008
Decision Date03/12/2008
Product Code
HEO[ Registered Establishments with HEO ]
Advisory Committee Obstetrics/Gynecology
Supplement Typereal-time process
Supplement Reason design change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a change to the patient interface box and cables.
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