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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.
 
Trade NameMODEL 3100A HIGH FREQUENCY OSCILLATORY VENTILATOR
Classification Nameventilator, high frequency
Generic Nameventilator
ApplicantCARDINAL HEALTH 207, INC.
PMA NumberP890057
Supplement NumberS019
Date Received01/03/2007
Decision Date04/25/2007
Product Code
LSZ[ Registered Establishments with LSZ ]
Advisory Committee Anesthesiology
Supplement Typereal-time process
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the modification of the breathing circuit to include two filters, one in the inspiratory limb after the gas supply line and relieve valve and another at the expiratory limb before the dump valve.
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