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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 1010 ULTRAHIGH FREQUENCY VENTILATOR
Classification Nameventilator, high frequency
Generic Nameventilator, high frequency
Applicant
Covidien
6135 gunbarrel ave.
boulder, CO 80301
PMA NumberP890034
Supplement NumberS005
Date Received06/12/1995
Decision Date12/28/1995
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
Approval Order Statement 
Approval for an proximal monitoring endotracheal tube adapter for use with the adult star model 1010 ultrahigh frequency ventilator - the proximal monitoring adapter will be marketed under the new trade name as the "proximal monitoring adapter".
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