FDA.reportPublic FDA data

PMA P850064S050

Device
LifePulse High Frequency Ventilator
Applicant
Bunnell, Inc.
PMA number
P850064
Supplement
S050
Product code
LSZ
Decision date
2023-05-31
Classification
Anesthesiology
Generic name
VENTILATOR, HIGH FREQUENCY
Approval order statement
Replace the Thermistor Inspection Fixtures with an upgraded design. This change would increase the ease and efficiency of performing incoming inspections of the 3” thermistors (P/N 00234) and 58” thermistors (P/N 00235) which are components in the Patient Circuit used in the LifePulse HFV Systems. The new Inspection Fixtures will not affect the safety or effectiveness of the Patient Circuit or the LifePulse HFV.

Current openFDA PMA Record#

Device
LifePulse High Frequency Ventilator
Applicant
Bunnell, Inc.
PMA number
P850064
Supplement
S050
Product code
LSZ
Generic name
VENTILATOR, HIGH FREQUENCY
Decision date
2023-05-31
Decision code
OK30
Date received
2023-05-10
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Replace the Thermistor Inspection Fixtures with an upgraded design. This change would increase the ease and efficiency of performing incoming inspections of the 3” thermistors (P/N 00234) and 58” thermistors (P/N 00235) which are components in the Patient Circuit used in the LifePulse HFV Systems. The new Inspection Fixtures will not affect the safety or effectiveness of the Patient Circuit or the LifePulse HFV.