510(k) K132402

SENSMART MODEL X-100 UNIVERAL OXIMETRY SYSTEM by Nonin Medical, Inc. — Product Code DQA

K132402 is an FDA 510(k) premarket notification submitted by Nonin Medical, Inc. for the device "SENSMART MODEL X-100 UNIVERAL OXIMETRY SYSTEM". The FDA issued a decision of Substantially Equivalent on February 21, 2014. The device falls under product code DQA (Oximeter), a Class II device regulated under 21 CFR 870.2700. Nonin Medical, Inc. has at least 10 other 510(k) clearances on record.