PMA P850064S046

Device
LifePulse High Frequency Ventilator
Applicant
Bunnell, Inc.
PMA number
P850064
Supplement
S046
Product code
LSZ
Decision date
2021-06-25
Generic name
VENTILATOR, HIGH FREQUENCY
Approval order statement
New process using the 844USB EPRO programmer.

Current openFDA PMA Record#

Device
LifePulse High Frequency Ventilator
Applicant
Bunnell, Inc.
PMA number
P850064
Supplement
S046
Product code
LSZ
Generic name
VENTILATOR, HIGH FREQUENCY
Decision date
2021-06-25
Decision code
OK30
Date received
2021-05-27
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
New process using the 844USB EPRO programmer.