Vasomedical Receives FDA 510k Clearance on Two New Devices

Vasomedical VASO today announced its receipt of U.S. FDA 510(k) clearance to market its Vasomedical-BIOX™ Model 2302 Combined 12-Channel ECG Holter/Ambulatory Blood Pressure Monitor and Model 1804 Ambulatory Blood Pressure Monitor. These new models complement the Company's already cleared Model 1305 3-Channel ECG Holter Monitor and Model 2301 Combined 3-Channel ECG Holter/Ambulatory Blood Pressure Monitor, and significantly expand its offering of BIOX series ambulatory patient monitoring products in the U.S. market under its exclusive North American Distributorship Agreement with BIOX Instruments Co., Ltd. based in Wuxi, China.
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