510(k) K022196

NATUS BLUE LIGHT PHOTOTHERAPY UNIT by Natus Medical, Inc. — Product Code LBI

K022196 is an FDA 510(k) premarket notification submitted by Natus Medical, Inc. for the device "NATUS BLUE LIGHT PHOTOTHERAPY UNIT". The FDA issued a decision of Substantially Equivalent on September 19, 2002. The device falls under product code LBI (Unit, Neonatal Phototherapy), a Class II device regulated under 21 CFR 880.5700. Natus Medical, Inc. has at least 10 other 510(k) clearances on record.