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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 NumberS009
Date Received05/16/1997
Decision Date07/08/1997
Product Code
LSZ[ Registered Establishments with LSZ ]
Advisory Committee Anesthesiology
Supplement Typenormal 180 day track
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a change in the manufacturing of the patient circuit to ultrasonic welding.
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