BEAR and BEAR mini— 510(k) K200803

Substantially Equivalent

Foreo, Inc.

FDA 510(k) clearance K200803 for BEAR and BEAR mini, Substantially Equivalent on 2020-07-31. Applicant: Foreo, Inc..

Clearance details

Applicant: Foreo, Inc.
Product code: Code NFO
Advisory panel: Neurology
Date received: 2020-03-27
Decision date: 2020-07-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Las Vegas, NV, US

Download summary PDF View on FDA.gov ↗

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