510(k) K983002

MYSTIQUE ULTRASONIC NEBULIZER by Airsep Corp. — Product Code CAF

K983002 is an FDA 510(k) premarket notification submitted by Airsep Corp. for the device "MYSTIQUE ULTRASONIC NEBULIZER". The FDA issued a decision of Substantially Equivalent on October 16, 1998. The device falls under product code CAF (Nebulizer (Direct Patient Interface)), a Class II device regulated under 21 CFR 868.5630. Airsep Corp. has at least 10 other 510(k) clearances on record.