510(k) K092785

COMBINED VASOMEDICAL-BIOX AMBULATORY ECG & BLOOD PRESSURE RECORDER & ANALYSIS SOFTWARE, 2301 by Vasomedical, Inc. — Product Code DSH

K092785 is an FDA 510(k) premarket notification submitted by Vasomedical, Inc. for the device "COMBINED VASOMEDICAL-BIOX AMBULATORY ECG & BLOOD PRESSURE RECORDER & ANALYSIS SOFTWARE, 2301". The FDA issued a decision of Substantially Equivalent on April 2, 2010. 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.