Spacelabs, Inc.

Spacelabs, Inc. — FDA 510(k) Submissions

Spacelabs, Inc. has submitted 46 FDA 510(k) premarket notifications since 1976, of which 46 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Detector And Alarm, Arrhythmia, Oximeter, System, Measurement, Blood-pressure, Non-invasive, Recorder, Magnetic Tape, Medical, Electrocardiograph . Use the specialty filter in the sidebar to narrow results.