NYTONE ENURETIC ALARM BEDWETTING DEVICE

NYTONE ENURETIC ALARM BEDWETTING DEVICE is an FDA 510(k)-cleared medical device (K844866) manufactured by Nytone Medical. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 2, 1985. Regulation: 8.