LungFit PH
FDA premarket approval P200044 · decided 2022-06-28
Approval details
- PMA number
- P200044
- Trade name
- LungFit PH
- Generic name
- Nitric Oxide Generator and Delivery System
- Applicant
- Beyond Air, Inc.
- Date received
- 2020-11-17
- Decision date
- 2022-06-28
- Days to decision
- 588 days
- Decision code
- APPR
- Product code
- QTB
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Garden City, NY
- Statement
- Approval for The LungFit® PH. The device is indicated to deliver nitric oxide (NO), a vasodilator, generated by the device into the inspiratory limb of the patient breathing circuit of a ventilator in a way that provides a constant concentration of NO, as set by the user, to the patient throughout the inspired breath. The LungFit® PH provides continuous integrated monitoring of inspired oxygen (O2), nitrogen dioxide (NO2) and NO, and a comprehensive alarm system. The LungFit® PH includes an inte
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