510(k) K953817

ARISTO MEDICAL MODEL 2101 PATIENT MONITOR by Aristo Medical Products, Inc. — Product Code DQA

K953817 is an FDA 510(k) premarket notification submitted by Aristo Medical Products, Inc. for the device "ARISTO MEDICAL MODEL 2101 PATIENT MONITOR". The FDA issued a decision of Substantially Equivalent on November 22, 1995. The device falls under product code DQA (Oximeter), a Class II device regulated under 21 CFR 870.2700. Aristo Medical Products, Inc. has at least 3 other 510(k) clearances on record.