510(k) K020739

BCI 3178 PEDIATRIC PULSE OXIMETRY SENSOR by Bci, Inc. — Product Code DQA

K020739 is an FDA 510(k) premarket notification submitted by Bci, Inc. for the device "BCI 3178 PEDIATRIC PULSE OXIMETRY SENSOR". The FDA issued a decision of Substantially Equivalent on June 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.