Galemed Corp.

Galemed Corp. — FDA 510(k) Submissions

Galemed Corp. has submitted 7 FDA 510(k) premarket notifications since 2002, of which 7 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Meter, Peak Flow, Spirometry, Ventilator, Non-continuous (respirator), Ventilator, Emergency, Manual (resuscitator), Monitor, Airway Pressure (includes Gauge And/or Alarm), Filter, Bacterial, Breathing-circuit . Use the specialty filter in the sidebar to narrow results.