R T VUE WITH SOFTWARE 5.0 MODEL: R I VUE 100— 510(k) K100861

Substantially Equivalent

Optovue, Inc.

FDA 510(k) clearance K100861 for R T VUE WITH SOFTWARE 5.0 MODEL: R I VUE 100, Substantially Equivalent on 2010-06-17. Applicant: Optovue, Inc..

Clearance details

Applicant: Optovue, Inc.
Product code: Code HLI
Advisory panel: Ophthalmic
Date received: 2010-03-26
Decision date: 2010-06-17
Decision: Substantially Equivalent
Clearance type: Special
Location: Fremont, CA, US

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