510(k) K111096

VASOMEDICAL-BIOX COMBINED 12 CHANNEL AMBULATORY ECG AND BLOOD PRESSURE RECORDER MODEL 2302, VASOMEDICAL-BIOX AMBULATORY by Vasomedical, Inc. — Product Code DSH

K111096 is an FDA 510(k) premarket notification submitted by Vasomedical, Inc. for the device "VASOMEDICAL-BIOX COMBINED 12 CHANNEL AMBULATORY ECG AND BLOOD PRESSURE RECORDER MODEL 2302, VASOMEDICAL-BIOX AMBULATORY". The FDA issued a decision of Substantially Equivalent on June 24, 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.