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FDA PMA

Nitric Oxide Generator and Delivery System

Número do PMA: P200044 · 2026-03-13

RequerenteBeyond Air, Inc.
Data da decisão2026-03-13
Número PMAP200044
Código do produtoQTB
Classe do DispositivoClasse 3
Especialidade MédicaU
Comité consultivoAN

Resumo do dispositivo

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.

Perguntas frequentes

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.

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Fonte oficial

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