PMA P850064S054
- Device
- LifePulse High Frequency Ventilator
- Applicant
- Bunnell, Inc.
- PMA number
- P850064
- Supplement
- S054
- Product code
- LSZ
- Decision date
- 2024-09-19
- Classification
- Anesthesiology
- Generic name
- VENTILATOR, HIGH FREQUENCY
- Approval order statement
- The sponsor has adequately addressed all concerns relating to the manufacturing procedure and equipment revisions implicated in this 30-day notice.
Current openFDA PMA Record#
- Device
- LifePulse High Frequency Ventilator
- Applicant
- Bunnell, Inc.
- PMA number
- P850064
- Supplement
- S054
- Product code
- LSZ
- Generic name
- VENTILATOR, HIGH FREQUENCY
- Decision date
- 2024-09-19
- Decision code
- OK30
- Date received
- 2024-08-26
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- The sponsor has adequately addressed all concerns relating to the manufacturing procedure and equipment revisions implicated in this 30-day notice.