FDA.reportPublic FDA data

PMA P850064S041

Device
LifePulse High Frequency Ventilator
Applicant
Bunnell, Inc.
PMA number
P850064
Supplement
S041
Product code
LSZ
Decision date
2019-11-22
Classification
Ventilator, High Frequency
Generic name
VENTILATOR, HIGH FREQUENCY
Approval order statement
For the LifePulse High Frequency Ventilator (HFV), to notify of a change to the manufacturing process and manufacturer of the priority alarm cover. The priority alarm cover is specific to the HFV 204.

Current openFDA PMA Record#

Device
LifePulse High Frequency Ventilator
Applicant
Bunnell, Inc.
PMA number
P850064
Supplement
S041
Product code
LSZ
Generic name
VENTILATOR, HIGH FREQUENCY
Decision date
2019-11-22
Decision code
OK30
Date received
2019-10-24
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
For the LifePulse High Frequency Ventilator (HFV), to notify of a change to the manufacturing process and manufacturer of the priority alarm cover. The priority alarm cover is specific to the HFV 204.