510(k) K013171

3420 DIGIT PULSE OXIMETER, MODEL 3420 by Bci, Inc. — Product Code DQA

K013171 is an FDA 510(k) premarket notification submitted by Bci, Inc. for the device "3420 DIGIT PULSE OXIMETER, MODEL 3420". The FDA issued a decision of Substantially Equivalent on January 3, 2002. The device falls under product code DQA (Oximeter), a Class II device regulated under 21 CFR 870.2700. Bci, Inc. has at least 10 other 510(k) clearances on record.