QTB · Nitric Oxide Generator And Delivery System
· Class 3
Overview
| Product Code | QTB |
|---|---|
| Device Name | Nitric Oxide Generator And Delivery System |
| Device Class | Class 3 |
| Review Panel | |
| Life-Sustaining | Yes |
Identification
The system is intended for generation and delivery of nitric oxide (NO) for use in conjunction with ventilatory support and other appropriate agents to produce, at point of care, and deliver nitric oxide (NO) to treat term and near-term (>34 weeks gestation) neonates with hypoxic respiratory failure associated with pulmonary hypertension. The system includes an integrated backup NO delivery system and gas analyzers with an alarm for monitoring of delivered NO, nitrogen dioxide (NO2), and oxygen (O2).
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| P200044 | LungFit PH | Beyond Air, Inc. | Jun 28, 2022 | APPR |
Top Applicants
- Beyond Air, Inc. — 1 clearance
