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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.
 
DeviceMODEL 3100B HIGH FREQUENCY OSCILLATORY VENTILATOR
Classification Nameventilator, high frequency
Generic Nameventilator, high frequency
Applicant
CareFusion
75 north fairway drive
vernon hills, IL 60061
PMA NumberP890057
Supplement NumberS017
Date Received07/14/2004
Decision Date02/25/2005
Product Code
LSZ[ Registered Establishments with LSZ ]
Advisory Committee Anesthesiology
Supplement Typenormal 180 day track no user fee
Supplement Reason location change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a manufacturing site located at bird products corporation, palm springs, california.
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