Zdrowie i gospodarka · 03/03/2000

FDA Classifies Nitric Oxide Devices into Class II with Special Controls

The FDA is classifying nitric oxide administration apparatus, analyzer, and nitrogen dioxide analyzer into Class II with special controls, following a petition under the Federal Food, Drug, and Cosmetic Act, as amended by the Medical Device Amendments of 1976 and the Safe Medical Devices Act of 1990.