510(k) K881308

BREATH-EASY by Icor AB — Product Code BYD

K881308 is an FDA 510(k) premarket notification submitted by Icor AB for the device "BREATH-EASY". The FDA issued a decision of Substantially Equivalent on May 17, 1988. 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.