PMA P200044S004
- Device
- LungFit PH
- Applicant
- Beyond Air, Inc.
- PMA number
- P200044
- Supplement
- S004
- Product code
- QTB
- Decision date
- 2023-09-29
- Classification
- Anesthesiology
- Generic name
- Nitric Oxide Generator and Delivery System
- Approval order statement
- Approval of a minor hardware change to allow the user to increase the alarm volume by moving a mechanical slider on the backside of the LungFit PH display.
Current openFDA PMA Record#
- Device
- LungFit PH
- Applicant
- Beyond Air, Inc.
- PMA number
- P200044
- Supplement
- S004
- Product code
- QTB
- Generic name
- Nitric Oxide Generator and Delivery System
- Decision date
- 2023-09-29
- Decision code
- APPR
- Date received
- 2023-06-30
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval of a minor hardware change to allow the user to increase the alarm volume by moving a mechanical slider on the backside of the LungFit PH display.