|
Device | 3100 HIGH FREQUENCY OSCILLATORY VENTILATOR (HFOV) |
Generic Name | VENTILATOR, HIGH FREQUENCY |
Applicant | Vyaire Medical Inc. 26125 Riverwoods Blvd Mettawa, IL 60045 |
PMA Number | P890057 |
Supplement Number | S021 |
Date Received | 10/28/2013 |
Decision Date | 11/22/2013 |
Product Code |
LSZ |
Advisory Committee |
Anesthesiology |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement CHANGE TO ADD A SUPPLIER FOR THE STOPCOCK. |