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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 NumberS006
Date Received05/21/2001
Decision Date11/09/2001
Product Code
MCP[ Registered Establishments with MCP ]
Advisory Committee Obstetrics/Gynecology
Supplement Typenormal 180 day track
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a manufacturing facility located at wipro ge medical systems, bangalore, india.
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