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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 ENDOTRACHEAL TUBE ADAPTER
Classification Nameventilator, high frequency
Generic Namehigh frequency ventilator
ApplicantBUNNELL, INC.
PMA NumberP850064
Supplement NumberS011
Date Received04/05/1995
Decision Date12/18/1995
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 
Appproval for an endotracheal tube adapter for use with the model 203 life pulse high frequency jet ventilator. The endotracheal tube adaptor will be marketed under the new trade name as the "lifeport" endotracheal tube adapter.
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