510(k) K850794

PATIENT MONITOR MODEL RM-300 by Honeywell, Inc. — Product Code DTR

K850794 is an FDA 510(k) premarket notification submitted by Honeywell, Inc. for the device "PATIENT MONITOR MODEL RM-300". The FDA issued a decision of Substantially Equivalent on April 18, 1985. The device falls under product code DTR (Heat-Exchanger, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4240. Honeywell, Inc. has at least 10 other 510(k) clearances on record.