FDA.reportPublic FDA data

PMA P850064S053

Device
LifePulse High Frequency Ventilator
Applicant
Bunnell, Inc.
PMA number
P850064
Supplement
S053
Product code
LSZ
Decision date
2023-12-28
Classification
Anesthesiology
Generic name
VENTILATOR, HIGH FREQUENCY
Approval order statement
approval for the filter element that is included in the Camozzi Filter Assembly. The filter element, made from HDPE, has gone from a white with pink speckles color to a light blue color. All other specifications remain the same and the color change is being made to differentiate between filter elements.

Current openFDA PMA Record#

Device
LifePulse High Frequency Ventilator
Applicant
Bunnell, Inc.
PMA number
P850064
Supplement
S053
Product code
LSZ
Generic name
VENTILATOR, HIGH FREQUENCY
Decision date
2023-12-28
Decision code
APPR
Date received
2023-09-29
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
approval for the filter element that is included in the Camozzi Filter Assembly. The filter element, made from HDPE, has gone from a white with pink speckles color to a light blue color. All other specifications remain the same and the color change is being made to differentiate between filter elements.