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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 OCILLATORY VENTILATOR
Classification Nameventilator, high frequency
Generic Nameventilator
ApplicantSENSOR MEDICS CORP.
PMA NumberP890057
Supplement NumberS007
Date Received02/26/1996
Decision Date12/20/1996
Product Code
LSZ[ Registered Establishments with LSZ ]
Advisory Committee Anesthesiology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for replacement flexible tubing and heated wire accessories and is indicated for use with mdoe 3100 and 3100a high frequency oscillatory ventilator.
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