FDA PMA Number P200044, LungFit PH
FDA PMA Number P200044, LungFit PH
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Contents: Premarket approval (PMA) P200044, LungFit PH, nitric oxide generator and delivery system, decision date June 28, 2022 (applicant—Beyond Air, Inc.)
Request Year: 2022
PMA Number: P200044
Device: LungFit PH
Generic Name: Nitric Oxide Generator and Delivery System
Manufacturer: Beyond Air, Inc.
Product Code: QTB
Date Received: 11/17/2020
Decision Date: 06/28/2022
Notice Date: 09/01/2022
- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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