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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.
 
Device3100 HIGH FREQUENCY OSCILLATORY VENTILATOR (HFOV)
Classification Nameventilator, high frequency
Generic Nameventilator, high frequency
Applicant
CareFusion
75 north fairway drive
vernon hills, IL 60061
PMA NumberP890057
Supplement NumberS021
Date Received10/28/2013
Decision Date11/22/2013
Product Code
LSZ[ Registered Establishments with LSZ ]
Advisory Committee Anesthesiology
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change to add a supplier for the stopcock.
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