510(k) K953507

TYPE 1 & 2 (HUMIDAIR I & II) by Icor AB — Product Code BYD

K953507 is an FDA 510(k) premarket notification submitted by Icor AB for the device "TYPE 1 & 2 (HUMIDAIR I & II)". The FDA issued a decision of Substantially Equivalent on September 7, 1995. The device falls under product code BYD (Condenser, Heat And Moisture (Artificial Nose)), a Class I device regulated under 21 CFR 868.5375. Icor AB has at least 10 other 510(k) clearances on record.