PMA P850064S031

Device
MODEL 204 LIFE PULSE HIGH FREQUENCY VENTILATOR
Applicant
Bunnell, Inc.
PMA number
P850064
Supplement
S031
Product code
LSZ
Decision date
2016-05-24
Classification
Ventilator, High Frequency
Generic name
VENTILATOR, HIGH FREQUENCY
Approval order statement
Approval for changing the screw material in the Patient Box model 314 of the Life Pulse High Frequency Ventilator.
Summary
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Current openFDA PMA Record#

Device
MODEL 204 LIFE PULSE HIGH FREQUENCY VENTILATOR
Applicant
Bunnell, Inc.
PMA number
P850064
Supplement
S031
Product code
LSZ
Generic name
VENTILATOR, HIGH FREQUENCY
Decision date
2016-05-24
Decision code
APPR
Date received
2016-02-24
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for changing the screw material in the Patient Box model 314 of the Life Pulse High Frequency Ventilator.