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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 3100B HIGH-FREQUENCY OSCILLATORY VENTILATORY (HFOV)
Classification Nameventilator, high frequency
Generic Nameventilator
ApplicantBIRD PRODUCTS CORP.
PMA NumberP890057
Supplement NumberS018
Date Received02/08/2005
Decision Date03/10/2005
Product Code
LSZ[ Registered Establishments with LSZ ]
Advisory Committee Anesthesiology
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for modifications to the heat and filter on the exhaled gas limb of the existing patient circuit.
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