PMA P850064S040
- Device
- LifePulse High Frequency Ventilator
- Applicant
- Bunnell, Inc.
- Product code
- LSZ
- Decision date
- 2020-02-14
- Generic name
- VENTILATOR, HIGH FREQUENCY
- Approval order statement
- Approval for changes in servicing of the LifePulse HFV model 204 (HFV 204) and Patient Box model 314 (Patient Box 314).
Current openFDA PMA Record#
- Device
- LifePulse High Frequency Ventilator
- Applicant
- Bunnell, Inc.
- PMA number
- P850064
- Supplement
- S040
- Product code
- LSZ
- Generic name
- VENTILATOR, HIGH FREQUENCY
- Decision date
- 2020-02-14
- Decision code
- APPR
- Date received
- 2019-07-31
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for changes in servicing of the LifePulse HFV model 204 (HFV 204) and Patient Box model 314 (Patient Box 314).