510(k) K083820

VASOMEDICAL BIOX CB-1305-C, 3 CHANNEL ECG HOLTER MONITOR, MODEL CB-1305-C by Vasomedical, Inc. — Product Code DSH

K083820 is an FDA 510(k) premarket notification submitted by Vasomedical, Inc. for the device "VASOMEDICAL BIOX CB-1305-C, 3 CHANNEL ECG HOLTER MONITOR, MODEL CB-1305-C". The FDA issued a decision of Substantially Equivalent on April 1, 2009. The device falls under product code DSH (Recorder, Magnetic Tape, Medical), a Class II device regulated under 21 CFR 870.2800. Vasomedical, Inc. has at least 6 other 510(k) clearances on record.