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PMA de la FDA

Nitric Oxide Generator and Delivery System

Número de PMA: P200044 · 2026-03-13

SolicitanteBeyond Air, Inc.
Fecha de decisión2026-03-13
Número PMAP200044
Código de productoQTB
Clase del dispositivoClase 3
Especialidad médicaU
Comité asesorIt appears you've provided the instruction but not the source text to translate. Please paste the English medical-device regulatory text you'd like translated into Spanish, and I'll translate it while preserving company/product names, FDA, 510(k), PMA, NCT, PMID, identifiers, and URLs.

Resumen del 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.

Preguntas frecuentes

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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Fuente oficial

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