510(k) K842275

ULTRASONIC COOL SPRAY HUMIDIFIER by Sunbeam Corp. — Product Code KFZ

K842275 is an FDA 510(k) premarket notification submitted by Sunbeam Corp. for the device "ULTRASONIC COOL SPRAY HUMIDIFIER". The FDA issued a decision of Substantially Equivalent on August 14, 1984. The device falls under product code KFZ (Humidifier, Non-Direct Patient Interface (Home-Use)), a Class I device regulated under 21 CFR 868.5460. Sunbeam Corp. has at least 2 other 510(k) clearances on record.