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Device | MODEL 3100A HIGH FREQUENCY OSCILLATORY VENTILATOR |
Generic Name | VENTILATOR, HIGH FREQUENCY |
Applicant | Vyaire Medical Inc. 26125 Riverwoods Blvd Mettawa, IL 60045 |
PMA Number | P890057 |
Supplement Number | S019 |
Date Received | 01/03/2007 |
Decision Date | 04/25/2007 |
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 THE MODIFICATION OF THE BREATHING CIRCUIT TO INCLUDE TWO FILTERS, ONE IN THE INSPIRATORY LIMB AFTER THE GAS SUPPLY LINE AND RELIEVE VALVE AND ANOTHER AT THE EXPIRATORY LIMB BEFORE THE DUMP VALVE. |