Epitel, Inc. - FDA 510(k) Cleared Devices

Epitel, Inc. has 4 FDA 510(k) cleared medical devices. Based in Salt Lake City, US.

Latest FDA clearance: Oct 2024. Active since 2021. Primary specialty: Neurology.

Browse the FDA 510(k) cleared devices submitted by Epitel, Inc. Filter by specialty or product code using the sidebar.

510(k) submissions have been managed by leanRAQA as regulatory consultant. 1 device has linked clinical trial registered on ClinicalTrials.gov. 1 submission has an FDA-authorized Predetermined Change Control Plan (PCCP), indicating AI or software-based device development.