510(k) K872371

ICOR NEONATAL HCH by Icor AB — Product Code BYD

K872371 is an FDA 510(k) premarket notification submitted by Icor AB for the device "ICOR NEONATAL HCH". The FDA issued a decision of Substantially Equivalent on September 4, 1987. 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.