510(k) K852124

HEMATOCRIT-SATURATION MONITOR HSM-100 by American Bentley — Product Code DRY

K852124 is an FDA 510(k) premarket notification submitted by American Bentley for the device "HEMATOCRIT-SATURATION MONITOR HSM-100". The FDA issued a decision of Substantially Equivalent on September 16, 1985. The device falls under product code DRY (Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4330. American Bentley has at least 10 other 510(k) clearances on record.