SMARTMIST ASTHMA MANAGMENT SYSTEM, SMARTMIST, MODEL NUMBER SM-100/SMARTMIST SPIROMETRY AIRWAY, MODEL NUMBER SA-100

SMARTMIST ASTHMA MANAGMENT SYSTEM, SMARTMIST, MODEL NUMBER SM-100/SMARTMIST SPIROMETRY AIRWAY, MODEL NUMBER SA-100 is an FDA 510(k)-cleared medical device (K960593) manufactured by Aradigm Corp.. This device is classified under the Anesthesiology specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on May 9, 1996. Regulation: 8.