Premarket Approval (PMA)

Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.

• Device: MODEL 3100 FREQUENCY OSCILLATORY VENTILATOR
• Generic Name: VENTILATOR, HIGH FREQUENCY
• Applicant: Vyaire Medical Inc.; 26125 Riverwoods Blvd; Mettawa, IL 60045
• PMA Number: P890057
• Date Received: 10/04/1989
• Decision Date: 03/29/1991
• Product Code: LSZ
• Docket Number: 91M-0142
• Notice Date: 04/25/1991
• Advisory Committee: Anesthesiology
• Expedited Review Granted?: No
• Combination Product: No
• Recalls: CDRH Recalls
• Supplements: S001 S002 S003 S004 S005 S007 S008 S009 S010 S013 S014 ; S015 S017 S018 S019 S020 S021 S022 S025 S028