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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.
 
DeviceMODEL 3100A FREQUENCY OSCILLATORY VENTILATOR
Classification Nameventilator, high frequency
Generic Nameventilator, high frequency
Applicant
CareFusion
75 north fairway drive
vernon hills, IL 60061
PMA NumberP890057
Supplement NumberS002
Date Received02/03/1992
Decision Date06/22/1992
Product Code
LSZ[ Registered Establishments with LSZ ]
Advisory Committee Anesthesiology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
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