510(k) K092101

REUSABLE PULSE OXIMETER SENSOR, MODEL 8000 SERIES by Nonin Medical, Inc. — Product Code DQA

K092101 is an FDA 510(k) premarket notification submitted by Nonin Medical, Inc. for the device "REUSABLE PULSE OXIMETER SENSOR, MODEL 8000 SERIES". The FDA issued a decision of Substantially Equivalent on October 21, 2009. 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.