510(k) K896153

MODIFIED DR-2C/PMC 100 by General Devices — Product Code DSH

K896153 is an FDA 510(k) premarket notification submitted by General Devices for the device "MODIFIED DR-2C/PMC 100". The FDA issued a decision of Substantially Equivalent on January 19, 1990. The device falls under product code DSH (Recorder, Magnetic Tape, Medical), a Class II device regulated under 21 CFR 870.2800. General Devices has at least 10 other 510(k) clearances on record.