PMA P850064S043
- Device
- LifePulse High Frequency Ventilator
- Applicant
- Bunnell, Inc.
- PMA number
- P850064
- Supplement
- S043
- Product code
- LSZ
- Decision date
- 2020-11-25
- Generic name
- VENTILATOR, HIGH FREQUENCY
- Approval order statement
- Change in the manufacturing process to add another Ultrasonic Welder Configuration for use in their Patient Circuit assembly.
Current openFDA PMA Record#
- Device
- LifePulse High Frequency Ventilator
- Applicant
- Bunnell, Inc.
- PMA number
- P850064
- Supplement
- S043
- Product code
- LSZ
- Generic name
- VENTILATOR, HIGH FREQUENCY
- Decision date
- 2020-11-25
- Decision code
- OK30
- Date received
- 2020-10-29
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change in the manufacturing process to add another Ultrasonic Welder Configuration for use in their Patient Circuit assembly.