510(k) K040831

DATEX-OHMEDA TRUSAT PULSE OXIMETER AND ACCESSORIES, MODEL 3500 by Datex-Ohmeda, Inc. — Product Code DPZ

K040831 is an FDA 510(k) premarket notification submitted by Datex-Ohmeda, Inc. for the device "DATEX-OHMEDA TRUSAT PULSE OXIMETER AND ACCESSORIES, MODEL 3500". The FDA issued a decision of Substantially Equivalent on September 2, 2004. The device falls under product code DPZ (Oximeter, Ear), a Class II device regulated under 21 CFR 870.2710. Datex-Ohmeda, Inc. has at least 10 other 510(k) clearances on record.