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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 NameYENNANT(TM) & KELMAN(TM) TYPE II
Classification Nametransducer, ultrasonic, obstetric
Regulation Number884.2960
PMA NumberP800016
Supplement NumberS015
Date Received12/20/1989
Decision Date09/28/1990
Product Code
HGL[ Registered Establishments with HGL ]
Advisory Committee Neurology
Supplement Typenormal 180 day track
Supplement Reason labeling change - other
Expedited Review Granted? No
Combination Product No
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