510(k) K113215

MODEL 7600 REGIONAL OXIMETER SYSTEM WITH EQUANOX TECHNOLOGY by Nonin Medical, Inc. — Product Code MUD

K113215 is an FDA 510(k) premarket notification submitted by Nonin Medical, Inc. for the device "MODEL 7600 REGIONAL OXIMETER SYSTEM WITH EQUANOX TECHNOLOGY". The FDA issued a decision of Substantially Equivalent on May 14, 2012. The device falls under product code MUD (Oximeter, Tissue Saturation), a Class II device regulated under 21 CFR 870.2700. Nonin Medical, Inc. has at least 10 other 510(k) clearances on record.