|
Device | LIFE PULSE HIGH FREQUENCY VENTILATOR |
Generic Name | VENTILATOR, HIGH FREQUENCY |
Applicant | BUNNELL, INC. 436 LAWNDALE DR. SALT LAKE CITY, UT 84115 |
PMA Number | P850064 |
Supplement Number | S023 |
Date Received | 06/10/2013 |
Decision Date | 05/15/2015 |
Product Code |
LSZ |
Advisory Committee |
Anesthesiology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE CHANGE THE THERMISTOR IN THE PATIENT CIRCUIT USED WITH THE LIFE PULSE HIGH FREQUENCY VENTILATOR. |