IVUE WITH NORMATIVE DATABASE— 510(k) K121739

Substantially Equivalent

Optovue, Inc.

FDA 510(k) clearance K121739 for IVUE WITH NORMATIVE DATABASE, Substantially Equivalent on 2013-01-18. Applicant: Optovue, Inc..

Clearance details

Applicant: Optovue, Inc.
Product code: Code HLI
Advisory panel: Ophthalmic
Date received: 2012-06-13
Decision date: 2013-01-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fremont, CA, US

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