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WebJun 28, 2024 · LungFit ® PH is the first FDA-approved product from Beyond Air’s LungFit ... As the first and only approved nitric oxide generator and delivery system, LungFit PH empowers healthcare providers to maximize the efficiency of a hospital when treating PPHN by moving beyond their reliance on traditional, inefficient delivery systems and the ... This guidance document was developed as a special controls guidance to support the classification of the breath nitric oxide test system into class II (Special Controls). A breath nitric oxide test system is a device intended to measure fractional nitric oxide in human breath. Measurement of changes in the … See more FDA believes that special controls, when combined with the general controls, will be sufficient to provide reasonable assurance of the safety and effectiveness of the breath nitric oxide … See more There are no known direct risks to patient health. However, failure of the test to perform as indicated or error in interpretation of … See more An Abbreviated 510(k) submission must include the required elements identified in 21 CFR 807.87, including the proposed labeling for the … See more The scope of this document is limited to the following devices as described in 21 CFR 862.3080 (product code: MXA). The classification … See more WebNitric oxide (Ingredient) Chemical formula: NO Drugbank ID: DB00435 ATC code: R07AX01. The information below refers to products available in the United States that … terror from beyond the stars