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

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