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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.
 
DeviceMODEL 203 LIFE PULSE HIGH FREQUENCY VENTILATOR
Generic NameVENTILATOR, HIGH FREQUENCY
ApplicantBUNNELL, INC.
436 LAWNDALE DR.
SALT LAKE CITY, UT 84115
PMA NumberP850064
Supplement NumberS002
Date Received02/09/1989
Decision Date03/15/1989
Product Code LSZ 
Advisory Committee Anesthesiology
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
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