Bio-Detek, Inc.

Bio-Detek, Inc. — FDA 510(k) Submissions

Bio-Detek, Inc. has submitted 17 FDA 510(k) premarket notifications since 1985, of which 17 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Automated External Defibrillators (non-wearable), Electrode, Electrocardiograph, Aid, Cardiopulmonary Resuscitation, Apparatus, Electrosurgical, Electrode, Cutaneous . Use the specialty filter in the sidebar to narrow results.