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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 NameCOROMETRICS MODEL 146 FETAL ACOUSTIC STIMULATOR, 0146
Classification Namestimulator, fetal, acoustic
Generic Namefetal acoustic stimulator
ApplicantWIPRO GE HEALTHCARE
PMA NumberP870025
Supplement NumberS011
Date Received09/10/2012
Decision Date10/10/2012
Product Code
MCP[ Registered Establishments with MCP ]
Advisory Committee Obstetrics/Gynecology
Supplement Type Special Supplement
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
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