510(k) K850181

AEQUITRON MED-7100 PHOTOTHERAPY LIGHT by Aequitron Medical, Inc. — Product Code LBI

K850181 is an FDA 510(k) premarket notification submitted by Aequitron Medical, Inc. for the device "AEQUITRON MED-7100 PHOTOTHERAPY LIGHT". The FDA issued a decision of Substantially Equivalent on April 5, 1985. The device falls under product code LBI (Unit, Neonatal Phototherapy), a Class II device regulated under 21 CFR 880.5700. Aequitron Medical, Inc. has at least 10 other 510(k) clearances on record.