FDA.reportPublic FDA data

PMA P850064S052

Device
LifePulse High Frequency Ventilator
Applicant
Bunnell, Inc.
PMA number
P850064
Supplement
S052
Product code
LSZ
Decision date
2024-06-21
Classification
Anesthesiology
Generic name
VENTILATOR, HIGH FREQUENCY
Approval order statement
The site was inspected in April 2024 and the EIR recommendation was VAI. Review of the report and the Firm's response were provided. The recommendation for the inspection is VAI.

Current openFDA PMA Record#

Device
LifePulse High Frequency Ventilator
Applicant
Bunnell, Inc.
PMA number
P850064
Supplement
S052
Product code
LSZ
Generic name
VENTILATOR, HIGH FREQUENCY
Decision date
2024-06-21
Decision code
APPR
Date received
2023-07-12
Supplement type
Normal 180 Day Track No User Fee
Supplement reason
Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
The site was inspected in April 2024 and the EIR recommendation was VAI. Review of the report and the Firm's response were provided. The recommendation for the inspection is VAI.