Ambu A/S

Ambu A/S — FDA 510(k) Submissions

Ambu A/S has submitted 37 FDA 510(k) premarket notifications since 2005, of which 37 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Bronchoscope (flexible Or Rigid), Cystoscope And Accessories, Flexible/rigid, Ventilator, Emergency, Manual (resuscitator), Nasopharyngoscope (flexible Or Rigid), Electrode, Electrocardiograph . Use the specialty filter in the sidebar to narrow results.