Prima, Inc.

Prima, Inc. — FDA 510(k) Submissions

Prima, Inc. has submitted 19 FDA 510(k) premarket notifications since 1994, of which 19 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Circuit, Breathing (w Connector, Adaptor, Y Piece), Set, Tubing And Support, Ventilator (w Harness), Connector, Airway (extension), Tube, Tracheal (w/wo Connector), Filter, Bacterial, Breathing-circuit . Use the specialty filter in the sidebar to narrow results.