510(k) K912000

TYPE INTERFACE 9271/1 INCUBATOR/WARMER by S & W Medico Teknik — Product Code FMZ

K912000 is an FDA 510(k) premarket notification submitted by S & W Medico Teknik for the device "TYPE INTERFACE 9271/1 INCUBATOR/WARMER". The FDA issued a decision of Substantially Equivalent on September 21, 1992. The device falls under product code FMZ (Incubator, Neonatal), a Class II device regulated under 21 CFR 880.5400. S & W Medico Teknik has at least 10 other 510(k) clearances on record.