Avanti— 510(k) K180660

Substantially Equivalent

Optovue, Inc.

FDA 510(k) clearance K180660 for Avanti, Substantially Equivalent on 2018-06-08. Applicant: Optovue, Inc..

Clearance details

Applicant: Optovue, Inc.
Product code: Code OBO
Advisory panel: Ophthalmic
Date received: 2018-03-14
Decision date: 2018-06-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fremont, CA, US

Download summary PDF View on FDA.gov ↗

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