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Device | MODEL 3100A HIGH FREQUENCY OCILLATORY VENTILATOR |
Generic Name | VENTILATOR, HIGH FREQUENCY |
Applicant | Vyaire Medical Inc. 26125 Riverwoods Blvd Mettawa, IL 60045 |
PMA Number | P890057 |
Supplement Number | S010 |
Date Received | 07/03/1997 |
Decision Date | 06/15/1998 |
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 changes to the oscillating mechanism and an increased range of continuous flow. |