Outset Medical, Inc.

Outset Medical, Inc. — FDA 510(k) Submissions

Outset Medical, Inc. has submitted 9 FDA 510(k) premarket notifications since 2016, of which 9 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Dialyzer, High Permeability With Or Without Sealed Dialysate System, Set, Tubing, Blood, With And Without Anti-regurgitation Valve . Use the specialty filter in the sidebar to narrow results.