BABE SHADE-INFANT AMBIENT LIGHT INTENSITY REDUCER

BABE SHADE-INFANT AMBIENT LIGHT INTENSITY REDUCER is an FDA 510(k)-cleared medical device (K853790) manufactured by Rocky Mountain Medical Corp.. This device is classified under the Ophthalmic specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on October 3, 1985. Regulation: 8.