- Device
- LungFit PH
- Applicant
- Beyond Air, Inc.
- PMA number
- P200044
- Supplement
- S005
- Product code
- QTB
- Generic name
- Nitric Oxide Generator and Delivery System
- Decision date
- 2023-10-20
- Decision code
- APPR
- Date received
- 2023-09-22
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- approval for a new calibration guide labeling document to provide additional clarification of the calibration instructions provided in the Operator’s Manual