510(k) K895935

ICOR CMU Q PLUS by Icor AB — Product Code BZL

K895935 is an FDA 510(k) premarket notification submitted by Icor AB for the device "ICOR CMU Q PLUS". The FDA issued a decision of Substantially Equivalent on January 4, 1990. The device falls under product code BZL (Computer, Oxygen-Uptake), a Class II device regulated under 21 CFR 868.1730. Icor AB has at least 10 other 510(k) clearances on record.