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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 | S027 |
Date Received | 08/25/2014 |
Decision Date | 02/13/2015 |
Product Code |
LSZ |
Advisory Committee |
Anesthesiology |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A NEW PATIENT BOX FOR THE DEVICE. |