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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
Classification Namestimulator, fetal, acoustic
Generic Namefetal acoustic stimulator
ApplicantGE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
PMA NumberP870025
Supplement NumberS005
Date Received02/08/1996
Decision Date07/17/1996
Product Code
MCP[ Registered Establishments with MCP ]
Advisory Committee Obstetrics/Gynecology
Supplement Typenormal 180 day track
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a labeling change to permit interface of the corometrics model 146 fetal acoustic stimulator with the corometrics model 155 fetal monitor.
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