510(k) K070291

MEDIX NATAL CARE INTENSIVE CARE INCUBATOR, MODELS-NATAL CARE ST-MX/LX/BX by Medix I.C.S.A. — Product Code FMZ

K070291 is an FDA 510(k) premarket notification submitted by Medix I.C.S.A. for the device "MEDIX NATAL CARE INTENSIVE CARE INCUBATOR, MODELS-NATAL CARE ST-MX/LX/BX". The FDA issued a decision of Substantially Equivalent on September 21, 2007. The device falls under product code FMZ (Incubator, Neonatal), a Class II device regulated under 21 CFR 880.5400. Medix I.C.S.A. has at least 5 other 510(k) clearances on record.