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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 204 LIFE PULSE HIGH FREQUENCY VENTILATOR
Generic NameVENTILATOR, HIGH FREQUENCY
ApplicantBunnell, Inc.
436 Lawndale Dr.
Salt Lake City, UT 84115
PMA NumberP850064
Supplement NumberS031
Date Received02/24/2016
Decision Date05/24/2016
Product Code LSZ 
Advisory Committee Anesthesiology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for changing the screw material in the Patient Box model 314 of the Life Pulse High Frequency Ventilator.
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