510(k) K974396

IRMA BLOOD ANALYSIS SYSTEM WITH OPTIONAL LIFESCAN SURESTEP PRO BLOOD GLUCOSE MODULE by Diametrics Medical, Inc. — Product Code CHL

K974396 is an FDA 510(k) premarket notification submitted by Diametrics Medical, Inc. for the device "IRMA BLOOD ANALYSIS SYSTEM WITH OPTIONAL LIFESCAN SURESTEP PRO BLOOD GLUCOSE MODULE". The FDA issued a decision of Substantially Equivalent on December 18, 1997. The device falls under product code CHL (Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph), a Class II device regulated under 21 CFR 862.1120. Diametrics Medical, Inc. has at least 10 other 510(k) clearances on record.