Apple, Inc.

Apple, Inc. — FDA 510(k) Submissions

Apple, Inc. has submitted 11 FDA 510(k) premarket notifications since 2018, of which 8 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Photoplethysmograph Analysis Software For Over-the-counter Use, Electrocardiograph Software For Over-the-counter Use, Digital Prismatic Correction, Air-conduction Hearing Aid Software, Over-the-counter Device To Assess Risk Of Sleep Apnea . Use the specialty filter in the sidebar to narrow results.