PMA P850064S030

Device
LIFE PULSE HIGH FREQUENCY VENTILATOR
Applicant
Bunnell, Inc.
PMA number
P850064
Supplement
S030
Product code
LSZ
Decision date
2016-12-23
Classification
Ventilator, High Frequency
Generic name
VENTILATOR, HIGH FREQUENCY
Approval order statement
Approval to add the 3.0 mm ID size LifePort Adapter to the existing product line of LifePort Adapters and adhesive changes to the approved LifePort Adapters.
Summary
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Current openFDA PMA Record#

Device
LIFE PULSE HIGH FREQUENCY VENTILATOR
Applicant
Bunnell, Inc.
PMA number
P850064
Supplement
S030
Product code
LSZ
Generic name
VENTILATOR, HIGH FREQUENCY
Decision date
2016-12-23
Decision code
APPR
Date received
2015-03-31
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval to add the 3.0 mm ID size LifePort Adapter to the existing product line of LifePort Adapters and adhesive changes to the approved LifePort Adapters.