510(k) K840858

OHIO 3300 INFANT WARMER SYSTEM by Ohio Medical Products — Product Code FMT

K840858 is an FDA 510(k) premarket notification submitted by Ohio Medical Products for the device "OHIO 3300 INFANT WARMER SYSTEM". The FDA issued a decision of Substantially Equivalent on March 23, 1984. The device falls under product code FMT (Warmer, Infant Radiant), a Class II device regulated under 21 CFR 880.5130. Ohio Medical Products has at least 10 other 510(k) clearances on record.