PMA P850064S023

Device
LIFE PULSE HIGH FREQUENCY VENTILATOR
Applicant
Bunnell, Inc.
PMA number
P850064
Supplement
S023
Product code
LSZ
Decision date
2015-05-15
Classification
Ventilator, High Frequency
Generic name
VENTILATOR, HIGH FREQUENCY
Approval order statement
APPROVAL FOR THE CHANGE THE THERMISTOR IN THE PATIENT CIRCUIT USED WITH THE LIFE PULSE HIGH FREQUENCY VENTILATOR.
Summary
<a href="#main" target="_new">Quick Links: Skip to main page content</a> <a href="#search_form" target="_new">Skip to Search</a> <a href="#fda-topmenu-home" target="_new">Skip to Topics Menu</a> <a href="#footer" target="_new">Skip to Common Links</a> <a href="#" target="_new"><img src="/scripts/includes/images/img_fdagov_font_adj_small.png" alt="Decrease font size" title="Decrease font size"/></a> <a href="#" target="_new"><img src="/scripts/includes/images/img_fdagov_font_adj_medium.png" alt="Return font size to normal" title="Return font size to normal"/></a> <a href="#" target="_new"><img src="/scripts/includes/images/img_fdagov_font_adj_large.png" alt="Increase font size" title="Increase font size"/></a> <a href="http://www.hhs.gov/" target="_new"><img id="rrimg1" border="0" src="/scripts/includes/images/img_fdagov_hhs_masthead_logo_r.png" alt="U.S. Department of Health and Human Services" title="U.S. Department of Health and Human Services"/></a> <a href="https://www.fda.gov/" target="_new"><img src="/scripts/includes/images/gov-fda-new-white.png" alt="FDA, U.S. Food and Drug Administration" border="0" title="FDA, U.S. Food and Drug Administration"/></a> <a href="https://www.fda.gov/news-events/interactive-media" target="_new">Follow FDA</a> <a href="https://www.fda.gov/about-fda/fda-en-espanol" target="_new">En Espa&ntilde;ol</a> <a href="javascript:document.getElementById('search_form').submit();" target="_new"><img src="/scripts/includes/images/img_fdagov_mast_search_button.png" alt="Search" title="Search this site"/></a> <a href="https://www.fda.gov/" target="_new"><span>Home</span></a> <a href="https://www.fda.gov/food" target="_new"><span>Food</span></a> <a href="https://www.fda.gov/Drugs" target="_new"><span>Drugs</span></a> <a href="https://www.fda.gov/Medical-Devices" target="_new"><span>Medical Devices</span></a> <a href="https://www.fda.gov/radiation-emitting-products" target="_new"><span>Radiation-Emitting Products</span></a> <a href="https://www.fda.gov/vaccines-blood-biologics" target="_new"><span>Vaccines, Blood &amp; Biologics</span></a> <a href="https://www.fda.gov/animal-veterinary" target="_new"><span>Animal &amp; Veterinary</span></a> <a href="https://www.fda.gov/cosmetics" target="_new"><span>Cosmetics</span></a> <a href="https://www.fda.gov/tobacco-products" target="_new"><span>Tobacco Products</span></a> <a href="javascript:window.print();" target="_new"><img src="/scripts/includes/images/img_fdagov_utility_icon_print.png" alt="Print" title="Print this page"/></a> <a href="http://www.addthis.com/bookmark.php?u508=true&v=152&amp;username=fdamain" target="_new"><img src="/scripts/includes/images/img_fdagov_utility_icon_share.png" alt="Share" title="Share this page"/></a> <a href="http://www.addthis.com/bookmark.php" target="_new"><img src="/scripts/includes/images/img_fdagov_utility_icon_email.png" alt="E-mail" title="E-mail this page"/></a> <a href="https://www.fda.gov/" target="_new">FDA Home</a> <a href="http://www.fda.gov/MedicalDevices/default.htm" target="_new">Medical Devices</a> <a href="http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Databases/default.htm" target="_new">Databases</a> <a href="/scripts/cdrh/devicesatfda/index.cfm" target="_new"><img src="../images/supersearch.gif" align="left" border="0" alt="Super Search Devices@FDA"></a>

Current openFDA PMA Record#

Device
LIFE PULSE HIGH FREQUENCY VENTILATOR
Applicant
Bunnell, Inc.
PMA number
P850064
Supplement
S023
Product code
LSZ
Generic name
VENTILATOR, HIGH FREQUENCY
Decision date
2015-05-15
Decision code
APPR
Date received
2013-06-10
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
APPROVAL FOR THE CHANGE THE THERMISTOR IN THE PATIENT CIRCUIT USED WITH THE LIFE PULSE HIGH FREQUENCY VENTILATOR.