iVue— 510(k) K163475

Substantially Equivalent

Optovue, Inc.

FDA 510(k) clearance K163475 for iVue, Substantially Equivalent on 2017-06-09. Applicant: Optovue, Inc..

Clearance details

Applicant: Optovue, Inc.
Product code: Code OBO
Advisory panel: Ophthalmic
Date received: 2016-12-12
Decision date: 2017-06-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fremont, CA, US

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