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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 | S009 |
Date Received | 05/16/1997 |
Decision Date | 07/08/1997 |
Product Code |
LSZ |
Advisory Committee |
Anesthesiology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR A CHANGE IN THE MANUFACTURING OF THE PATIENT CIRCUIT TO ULTRASONIC WELDING. |