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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 NameHFV STAR (NEW MANUFACTURING SITE)
Classification Nameventilator, high frequency
Generic Namehigh frequency ventilator
ApplicantINFRASONICS CORP.
PMA NumberP880013
Supplement NumberS002
Date Received04/10/1992
Decision Date08/11/1993
Product Code
LSZ[ Registered Establishments with LSZ ]
Advisory Committee Anesthesiology
Supplement Typenormal 180 day track
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product No
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