510(k) K834611

SINGUL-XR RP NON SCREEN MED. FILM by Cea America Corp. — Product Code IWZ

K834611 is an FDA 510(k) premarket notification submitted by Cea America Corp. for the device "SINGUL-XR RP NON SCREEN MED. FILM". The FDA issued a decision of Substantially Equivalent on February 21, 1984. The device falls under product code IWZ (Film, Radiographic), a Class I device regulated under 21 CFR 892.1840. Cea America Corp. has at least 4 other 510(k) clearances on record.