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Vasomedical patient monitors receive FDA 510(k) clearance

Vasomedical has received the US Food and Drug Administration (FDA) 510(k) clearance for Vasomedical-BIOX Model 2302 Combined 12-Channel ECG Holter/Ambulatory Blood Pressure Monitor and Model 1804 Ambulatory Blood Pressure Monitor.

With the new clearance, Vasomedical now provides both 3-channel (Model 2301) and 12-channel (Model 2302) Combined Holter ECG/ABP Monitors.

The new models complement the company’s previously cleared Model 1305 3-Channel ECG Holter Monitor and Model 2301 Combined 3-Channel ECG Holter/Ambulatory Blood Pressure Monitor.

The products expand the offering of BIOX series ambulatory patient monitoring products in the US under the company’s exclusive North American distributorship agreement with China-based BIOX Instruments.

Vasomedical president and CEO Jun Ma said these and other new product offerings along with their core, proprietary enhanced external counterpulsation (EECP) therapy systems provide patients, physicians and payers solutions to meet the challenges of delivering cost-effective healthcare.

All Vasomedical-BIOX series monitors work with the CB Series Analysis Software, also previously cleared by the FDA, for data scanning, analysis and reporting.