Breas Medical AB

Breas Medical AB — FDA 510(k) Submissions

Breas Medical AB has submitted 15 FDA 510(k) premarket notifications since 2006, of which 15 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Ventilator, Continuous, Minimal Ventilatory Support, Facility Use, Ventilator, Non-continuous (respirator), Continuous, Ventilator, Home Use, Ventilator, Continuous, Non-life-supporting, Humidifier, Respiratory Gas, (direct Patient Interface) . Use the specialty filter in the sidebar to narrow results.