PMA P850064S051
- Device
- LifePulse High Frequency Ventilator
- Applicant
- Bunnell, Inc.
- PMA number
- P850064
- Supplement
- S051
- Product code
- LSZ
- Decision date
- 2023-12-28
- Classification
- Anesthesiology
- Generic name
- VENTILATOR, HIGH FREQUENCY
- Approval order statement
- approval for a change in the formulation of the resin material for the LifePort Adapter.
Current openFDA PMA Record#
- Device
- LifePulse High Frequency Ventilator
- Applicant
- Bunnell, Inc.
- PMA number
- P850064
- Supplement
- S051
- Product code
- LSZ
- Generic name
- VENTILATOR, HIGH FREQUENCY
- Decision date
- 2023-12-28
- Decision code
- APPR
- Date received
- 2023-05-31
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- approval for a change in the formulation of the resin material for the LifePort Adapter.