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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
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 NumberS006
Date Received08/01/1991
Decision Date01/09/1992
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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