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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
Classification Nameventilator, high frequency
Generic Nameventilator, high frequency
75 north fairway drive
vernon hills, IL 60061
PMA NumberP890057
Supplement NumberS014
Date Received02/22/2001
Decision Date09/24/2001
Product Code
LSZ[ Registered Establishments with LSZ ]
Docket Number 01M-0520
Notice Date 11/19/2001
Advisory Committee Anesthesiology
Supplement Typepanel 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