Sterile Water for Inhalation in 1L Flexoval ® bottles.

Sterile Water for Inhalation in 1L Flexoval ® bottles. is an FDA 510(k)-cleared medical device (K223551) manufactured by Hometa, Inc.. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 2, 2023. Regulation: 8.