510(k) K980523

IRMA BLOOD ANALYSIS SYSTEM WITH OPTIONAL MULTI-USE CARTRIDGE by Diametrics Medical, Inc. — Product Code CHL

K980523 is an FDA 510(k) premarket notification submitted by Diametrics Medical, Inc. for the device "IRMA BLOOD ANALYSIS SYSTEM WITH OPTIONAL MULTI-USE CARTRIDGE". The FDA issued a decision of Substantially Equivalent on March 19, 1998. 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.