510(k) K013273

FUKUDA DENSHI MODEL HG-500, PULSE OXIMETER MODULE by Fukuda Denshi USA, Inc. — Product Code DQA

K013273 is an FDA 510(k) premarket notification submitted by Fukuda Denshi USA, Inc. for the device "FUKUDA DENSHI MODEL HG-500, PULSE OXIMETER MODULE". The FDA issued a decision of Substantially Equivalent on December 20, 2001. The device falls under product code DQA (Oximeter), a Class II device regulated under 21 CFR 870.2700. Fukuda Denshi USA, Inc. has at least 10 other 510(k) clearances on record.