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PMA P850064S039

Device
LifePulse High Frequency Ventilator
Applicant
Bunnell, Inc.
PMA number
P850064
Supplement
S039
Product code
LSZ
Decision date
2019-06-14
Classification
Ventilator, High Frequency
Generic name
VENTILATOR, HIGH FREQUENCY
Approval order statement
Approval for the manufacturer of the injection molded parts including the Patient Circuit Cartridge halves, Cartridge Back and Cartridge Front, and the LifePort Adapters Patient End and Machine End, all sizes.

Current openFDA PMA Record#

Device
LifePulse High Frequency Ventilator
Applicant
Bunnell, Inc.
PMA number
P850064
Supplement
S039
Product code
LSZ
Generic name
VENTILATOR, HIGH FREQUENCY
Decision date
2019-06-14
Decision code
APPR
Date received
2019-02-27
Supplement type
135 Review Track For 30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Approval for the manufacturer of the injection molded parts including the Patient Circuit Cartridge halves, Cartridge Back and Cartridge Front, and the LifePort Adapters Patient End and Machine End, all sizes.