PMA P200044
- Device
- LungFit PH
- Applicant
- Beyond Air, Inc.
- PMA number
- P200044
- Supplement
- S001
- Product code
- QTB
- Decision date
- 2026-03-13
- Generic name
- Nitric Oxide Generator and Delivery System
- Approval order statement
- approval of additional in-process tests for PCBA inspection
Current openFDA PMA Record#
- Device
- LungFit PH
- Applicant
- Beyond Air, Inc.
- PMA number
- P200044
- Supplement
- S013
- Product code
- QTB
- Generic name
- Nitric Oxide Generator and Delivery System
- Decision date
- 2026-03-13
- Decision code
- OK30
- Date received
- 2026-02-12
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- approval of additional in-process tests for PCBA inspection