PnueAira (PNCU-01)

PnueAira (PNCU-01) is an FDA 510(k)-cleared medical device (K251086) manufactured by Biotab, LLC. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 17, 2025. Regulation: 8.