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FDA PMA

Nitric Oxide Generator and Delivery System

PMA Number: P200044 · 2026-03-13

ApplicantBeyond Air, Inc.
Decision Date2026-03-13
PMA NumberP200044
Product CodeQTB
Device ClassClass 3
Medical SpecialtyU
Advisory CommitteeAN

Device Summary

Nitric Oxide Generator and Delivery System is the device name listed in this FDA 510(k) record. The listed applicant is Beyond Air, Inc.. It received FDA 510(k) clearance on 2026-03-13. The device is classified under product code QTB. It was reviewed by the AN advisory panel.

Frequently Asked Questions

What is the Nitric Oxide Generator and Delivery System?

Nitric Oxide Generator and Delivery System is a medical device that received FDA 510(k) clearance on 2026-03-13. The listed applicant is Beyond Air, Inc..

When did Nitric Oxide Generator and Delivery System receive FDA 510(k) clearance?

The clearance date for Nitric Oxide Generator and Delivery System can be found in the official FDA records.

Who is the listed applicant for Nitric Oxide Generator and Delivery System?

The FDA 510(k) record lists Beyond Air, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Nitric Oxide Generator and Delivery System?

The FDA product code for Nitric Oxide Generator and Delivery System is QTB.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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