510(k) K111180

VASOMEDICAL-BIOX 12- CHANNEL AMBULATORY ECG HOLTER RECORDER MODEL 1304, VASOMEDICAL-BIOX 3- CHANNEL MINIATURE AMBULATORY by Vasomedical, Inc. — Product Code DSH

K111180 is an FDA 510(k) premarket notification submitted by Vasomedical, Inc. for the device "VASOMEDICAL-BIOX 12- CHANNEL AMBULATORY ECG HOLTER RECORDER MODEL 1304, VASOMEDICAL-BIOX 3- CHANNEL MINIATURE AMBULATORY". The FDA issued a decision of Substantially Equivalent on June 28, 2011. 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.