LungFit PH
FDA premarket approval P200044/S004 · decided 2023-09-29
Approval details
- PMA number
- P200044
- Supplement
- S004
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- LungFit PH
- Generic name
- Nitric Oxide Generator and Delivery System
- Applicant
- Beyond Air, Inc.
- Date received
- 2023-06-30
- Decision date
- 2023-09-29
- Days to decision
- 91 days
- Decision code
- APPR
- Product code
- QTB
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Garden City, NY
- 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.
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