|
Device | MODEL 3100B 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 | S014 |
Date Received | 02/22/2001 |
Decision Date | 09/24/2001 |
Product Code |
LSZ |
Docket Number | 01M-0520 |
Notice Date | 11/19/2001 |
Advisory Committee |
Anesthesiology |
Supplement Type | Panel Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE MODEL 3100B HFOV. THE DEVICE IS INDICATED FOR USE IN THE VENTILATORY SUPPORT AND TREATMENT OF SELECTED PATIENTS 35 KILOGRAMS AND GREATER WITH ACUTE RESPIRATORY FAILURE. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
|