PMA
P200044: LungFit PH
FDA PMA · Nitric Oxide Generator and Delivery System · Beyond Air, Inc.
Key facts
| PMA number | P200044 |
|---|---|
| Trade name | LungFit PH |
| Generic name | Nitric Oxide Generator and Delivery System |
| Applicant | Beyond Air, Inc. |
| Owner/operator | Beyond Air Inc. |
| Product code | QTB |
| Approval date | Jun 28, 2022 |
| Docket number | 22M-2064 |
| Notice date | Sep 1, 2022 |
| Establishment registration | 3020846279 |
| FEI number | 3020846279 |
At a glance
- 10–99 Supplements
- Mar 13, 2026 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 10–99 UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: