FDA.reportPublic FDA data

PMA P850064S045

Device
Life Pulse High Frequency Ventilator
Applicant
Bunnell, Inc.
Product code
LSZ
Decision date
2021-10-13
Generic name
VENTILATOR, HIGH FREQUENCY
Approval order statement
Approval for a change to the manufacturing process of cutting the heater wire, including the process of stripping the ends of the cut heater wire. It is proposed that an approved vendor perform the requested tasks.

Current openFDA PMA Record#

Device
Life Pulse High Frequency Ventilator
Applicant
Bunnell, Inc.
PMA number
P850064
Supplement
S045
Product code
LSZ
Generic name
VENTILATOR, HIGH FREQUENCY
Decision date
2021-10-13
Decision code
APPR
Date received
2021-02-16
Supplement type
135 Review Track For 30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Approval for a change to the manufacturing process of cutting the heater wire, including the process of stripping the ends of the cut heater wire. It is proposed that an approved vendor perform the requested tasks.