PMA P200044S011
- Device
- LungFit PH
- Applicant
- Beyond Air, Inc.
- PMA number
- P200044
- Supplement
- S011
- Product code
- QTB
- Decision date
- 2025-05-06
- Classification
- Anesthesiology
- Generic name
- Nitric Oxide Generator and Delivery System
- Approval order statement
- approval for the replacement of a sensor component
Current openFDA PMA Record#
- Device
- LungFit PH
- Applicant
- Beyond Air, Inc.
- PMA number
- P200044
- Supplement
- S011
- Product code
- QTB
- Generic name
- Nitric Oxide Generator and Delivery System
- Decision date
- 2025-05-06
- Decision code
- APPR
- Date received
- 2025-02-05
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- approval for the replacement of a sensor component