|
Device | MODEL 3100B HIGH-FREQUENCY OSCILLATORY VENTILATORY (HFOV) |
Generic Name | VENTILATOR, HIGH FREQUENCY |
Applicant | Vyaire Medical Inc. 26125 Riverwoods Blvd Mettawa, IL 60045 |
PMA Number | P890057 |
Supplement Number | S018 |
Date Received | 12/20/2004 |
Decision Date | 03/10/2005 |
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 MODIFICATIONS TO THE HEAT AND FILTER ON THE EXHALED GAS LIMB OF THE EXISTING PATIENT CIRCUIT. |