510(k) K892227

EDENTEC MODEL 2001 MODULAR MEMORY UNIT (MMU) by Edentec Corp. — Product Code DSH

K892227 is an FDA 510(k) premarket notification submitted by Edentec Corp. for the device "EDENTEC MODEL 2001 MODULAR MEMORY UNIT (MMU)". The FDA issued a decision of Substantially Equivalent on June 20, 1989. The device falls under product code DSH (Recorder, Magnetic Tape, Medical), a Class II device regulated under 21 CFR 870.2800. Edentec Corp. has at least 10 other 510(k) clearances on record.