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Device | MODEL 204 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 | S031 |
Date Received | 02/24/2016 |
Decision Date | 05/24/2016 |
Product Code |
LSZ |
Advisory Committee |
Anesthesiology |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for changing the screw material in the Patient Box model 314 of the Life Pulse High Frequency Ventilator. |