510(k) K771263

RADIOMHTER OSM-2 HEMOXIMETER by The London Co. — Product Code GHS

K771263 is an FDA 510(k) premarket notification submitted by The London Co. for the device "RADIOMHTER OSM-2 HEMOXIMETER". The FDA issued a decision of Substantially Equivalent on August 3, 1977. The device falls under product code GHS (Assay, Carboxyhemoglobin), a Class II device regulated under 21 CFR 864.7425. The London Co. has at least 6 other 510(k) clearances on record.