510(k) K031153

MONITOR, MODEL HSM-00200; PROBE, MODEL HSP-05065; JACKET, MODEL HSJ-05065 by Arrow Intl., Inc. — Product Code DPW

K031153 is an FDA 510(k) premarket notification submitted by Arrow Intl., Inc. for the device "MONITOR, MODEL HSM-00200; PROBE, MODEL HSP-05065; JACKET, MODEL HSJ-05065". The FDA issued a decision of Substantially Equivalent on November 25, 2003. The device falls under product code DPW (Flowmeter, Blood, Cardiovascular), a Class II device regulated under 21 CFR 870.2100. Arrow Intl., Inc. has at least 10 other 510(k) clearances on record.