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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 NameLIFE PULSE HIGH FREQUENCY VENTILATOR, MODELS 203 AND 203A
Classification Nameventilator, high frequency
Generic Namehigh frequency ventilator
ApplicantBUNNELL, INC.
PMA NumberP850064
Supplement NumberS018
Date Received02/22/2010
Decision Date08/20/2010
Product Code
LSZ[ Registered Establishments with LSZ ]
Advisory Committee Anesthesiology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a modification to the ventilator software.
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