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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 203 LIFE PULSE HIGH FREQUENCY VENTILATOR
Classification Nameventilator, high frequency
Generic Nameventilator, high frequency
Applicant
BUNNELL, INC.
436 lawndale dr.
salt lake city, UT 84115
PMA NumberP850064
Supplement NumberS002
Date Received02/09/1989
Decision Date03/15/1989
Product Code
LSZ[ Registered Establishments with LSZ ]
Advisory Committee Anesthesiology
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
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