• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
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 NameLIFE PULSE HIGH FREQUENCY VENTILATOR
Classification Nameventilator, high frequency
Generic Namehigh frequency ventilator
ApplicantBUNNELL, INC.
PMA NumberP850064
Supplement NumberS016
Date Received09/10/1999
Decision Date10/05/1999
Product Code
LSZ[ Registered Establishments with LSZ ]
Advisory Committee Anesthesiology
Supplement Type Special Supplement
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the addition of three warnings.
-
-