510(k) K912908

AIR-SHIELDS MICRO-LITE PHOTOTHERAPY SYSTEM by Air-Shields Vickers, Inc. — Product Code LBI

K912908 is an FDA 510(k) premarket notification submitted by Air-Shields Vickers, Inc. for the device "AIR-SHIELDS MICRO-LITE PHOTOTHERAPY SYSTEM". The FDA issued a decision of Substantially Equivalent on December 13, 1991. The device falls under product code LBI (Unit, Neonatal Phototherapy), a Class II device regulated under 21 CFR 880.5700. Air-Shields Vickers, Inc. has at least 8 other 510(k) clearances on record.