510(k) K833823

HOLTER PERFORMER FEATHER WEIGHT/CASS by Applied Cardiac Systems — Product Code DSH

K833823 is an FDA 510(k) premarket notification submitted by Applied Cardiac Systems for the device "HOLTER PERFORMER FEATHER WEIGHT/CASS". The FDA issued a decision of Substantially Equivalent on December 1, 1983. The device falls under product code DSH (Recorder, Magnetic Tape, Medical), a Class II device regulated under 21 CFR 870.2800. Applied Cardiac Systems has at least 4 other 510(k) clearances on record.