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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceLIFE PULSE HIGH FREQUENCY VENTILATOR ENDOTRACHEAL TUBE ADAPTER
Generic NameVENTILATOR, HIGH FREQUENCY
ApplicantBUNNELL, INC.
436 LAWNDALE DR.
SALT LAKE CITY, UT 84115
PMA NumberP850064
Supplement NumberS011
Date Received04/05/1995
Decision Date12/18/1995
Product Code LSZ 
Advisory Committee Anesthesiology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
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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