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Device | LIFE PULSE HIGH FREQUENCY VENTILATOR ENDOTRACHEAL TUBE ADAPTER |
Generic Name | VENTILATOR, HIGH FREQUENCY |
Applicant | BUNNELL, INC. 436 LAWNDALE DR. SALT LAKE CITY, UT 84115 |
PMA Number | P850064 |
Supplement Number | S011 |
Date Received | 04/05/1995 |
Decision Date | 12/18/1995 |
Product Code |
LSZ |
Advisory Committee |
Anesthesiology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPPROVAL FOR AN ENDOTRACHEAL TUBE ADAPTER FOR USE WITH THE MODEL 203 LIFE PULSE HIGH FREQUENCY JET VENTILATOR. THE ENDOTRACHEAL TUBE ADAPTOR WILL BE MARKETED UNDER THE NEW TRADE NAME AS THE "LIFEPORT" ENDOTRACHEAL TUBE ADAPTER |