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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, PATIENT BOX
Generic NameVENTILATOR, HIGH FREQUENCY
ApplicantBunnell, Inc.
436 Lawndale Dr.
Salt Lake City, UT 84115
PMA NumberP850064
Supplement NumberS028
Date Received02/04/2015
Decision Date12/17/2015
Product Code LSZ 
Advisory Committee Anesthesiology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL TO UPGRADE THE LIFE PULSE HIGH LIFE PULSE HIGH FREQUENCY VENTILATOR 204 AND PATIENT BOX 213.
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