510(k) K093853

SINGLE-PATIENT USE DISPOSABLE SENSOR SERIES by Nonin Medical, Inc. — Product Code DQA

K093853 is an FDA 510(k) premarket notification submitted by Nonin Medical, Inc. for the device "SINGLE-PATIENT USE DISPOSABLE SENSOR SERIES". The FDA issued a decision of Substantially Equivalent on June 4, 2010. 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.