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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameMODEL 3100 FREQUENCY OSCILLATORY VENTILATOR
Classification Nameventilator, high frequency
Generic Namehigh frequency ventilator
ApplicantCAREFUSION
PMA NumberP890057
Date Received10/04/1989
Decision Date03/29/1991
Product Code
LSZ[ Registered Establishments with LSZ ]
Docket Number 91M-0142
Notice Date 04/25/1991
Advisory Committee Anesthesiology
Expedited Review Granted? No
Combination Product No
Supplements: S001 S002 S003 S004 S005 S007 
S008 S009 S010 S013 S014 S015 
S017 S018 S019 S020 
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