510(k) K203827— REMI

Substantially Equivalent

Epitel, Inc.

Clearance details

Applicant: Epitel, Inc.
Product code: Code OMC
Advisory panel: Neurology
Date received: 2020-12-29
Decision date: 2021-03-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Salt Lake City, UT, US

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.