PMA P850064S042
- Device
- LifePulse High Frequency Ventilator
- Applicant
- Bunnell, Inc.
- PMA number
- P850064
- Supplement
- S042
- Product code
- LSZ
- Decision date
- 2019-12-13
- Generic name
- VENTILATOR, HIGH FREQUENCY
- Approval order statement
- Change to a test fixture used for the Patient Circuit post assembly.
Current openFDA PMA Record#
- Device
- LifePulse High Frequency Ventilator
- Applicant
- Bunnell, Inc.
- PMA number
- P850064
- Supplement
- S042
- Product code
- LSZ
- Generic name
- VENTILATOR, HIGH FREQUENCY
- Decision date
- 2019-12-13
- Decision code
- OK30
- Date received
- 2019-11-15
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change to a test fixture used for the Patient Circuit post assembly.