510(k) K001242

ISOLETTE INFANT INCUBATOR, MODEL C2HS by Hill-Rom Air-Shields — Product Code FMZ

K001242 is an FDA 510(k) premarket notification submitted by Hill-Rom Air-Shields for the device "ISOLETTE INFANT INCUBATOR, MODEL C2HS". The FDA issued a decision of Substantially Equivalent on July 13, 2000. The device falls under product code FMZ (Incubator, Neonatal), a Class II device regulated under 21 CFR 880.5400. Hill-Rom Air-Shields has at least 4 other 510(k) clearances on record.