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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.
 
DeviceLifePulse High Frequency Ventilator (LifePulse HFV) Model 204
Generic NameVENTILATOR, HIGH FREQUENCY
ApplicantBunnell, Inc.
436 Lawndale Dr.
Salt Lake City, UT 84115
PMA NumberP850064
Supplement NumberS058
Date Received04/13/2026
Decision Date05/07/2026
Product Code LSZ 
Advisory Committee Anesthesiology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
This is a 30-DN to provide the change in power cord testing as a result of a CAPA investigation into a miswiring of one single power cord. the testing is adequate to test the incoming inspection for cross-wired power cords and not as a complete safety check.
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