510(k) K802126

ISOLETTE INCUBATOR C-100 by Narco Air-Shields — Product Code FMZ

K802126 is an FDA 510(k) premarket notification submitted by Narco Air-Shields for the device "ISOLETTE INCUBATOR C-100". The FDA issued a decision of Substantially Equivalent on September 26, 1980. The device falls under product code FMZ (Incubator, Neonatal), a Class II device regulated under 21 CFR 880.5400. Narco Air-Shields has at least 10 other 510(k) clearances on record.