510(k) K865012

YSI MODEL 801 by Yellow Springs Instrument Co., Inc. — Product Code FMT

K865012 is an FDA 510(k) premarket notification submitted by Yellow Springs Instrument Co., Inc. for the device "YSI MODEL 801". The FDA issued a decision of Substantially Equivalent on March 4, 1987. The device falls under product code FMT (Warmer, Infant Radiant), a Class II device regulated under 21 CFR 880.5130. Yellow Springs Instrument Co., Inc. has at least 10 other 510(k) clearances on record.