|
Device | MODEL 3100B HIGH FREQUENCY OSCILLATORY VENTILATOR |
Generic Name | VENTILATOR, HIGH FREQUENCY |
Applicant | Vyaire Medical Inc. 26125 Riverwoods Blvd Mettawa, IL 60045 |
PMA Number | P890057 |
Supplement Number | S017 |
Date Received | 07/14/2004 |
Decision Date | 02/25/2005 |
Product Code |
LSZ |
Advisory Committee |
Anesthesiology |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR A MANUFACTURING SITE LOCATED AT BIRD PRODUCTS CORPORATION, PALM SPRINGS, CALIFORNIA. |