510(k) K001439

ORTHOCEPH OC100 D by Instrumentarium Corp. — Product Code MUH

K001439 is an FDA 510(k) premarket notification submitted by Instrumentarium Corp. for the device "ORTHOCEPH OC100 D". The FDA issued a decision of Substantially Equivalent on June 22, 2000. The device falls under product code MUH (System, X-Ray, Extraoral Source, Digital), a Class II device regulated under 21 CFR 872.1800. Instrumentarium Corp. has at least 10 other 510(k) clearances on record.