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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.
 
DeviceCOROMETRICS MODEL 146 FETAL ACOUSTIC STIMULATOR
Classification Namestimulator, fetal, acoustic
Generic Namestimulator, fetal, acoustic
Applicant
GE MEDICAL SYSTEMS, INC.
4502 woodland corporate blvd
tamp, FL 33614
PMA NumberP870025
Supplement NumberS003
Date Received01/27/1995
Decision Date04/13/1995
Product Code
MCP[ Registered Establishments with MCP ]
Advisory Committee Obstetrics/Gynecology
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
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