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

Name: FDA 510(k) clearance K100861
Creator: U.S. Food and Drug Administration
Published: 2010-06-17

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.. Device class: 2.

Clearance details

Applicant: Optovue, Inc.
Product code: Code HLI
Device class: Class 2
Regulation: 21 CFR 886.1570
Advisory panel: Ophthalmic
Date received: 2010-03-26
Decision date: 2010-06-17
Decision: Substantially Equivalent
Clearance type: Special
Location: Fremont, CA, US

Download summary PDF View on FDA.gov ↗

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