Cleared Special

R T VUE WITH SOFTWARE 5.0 MODEL: R I VUE 100

K100861 · Optovue, Inc. · Ophthalmic
Jun 2010
Decision
83d
Days
Class 2
Risk

About This 510(k) Submission

K100861 is an FDA 510(k) clearance for the R T VUE WITH SOFTWARE 5.0 MODEL: R I VUE 100, a Ophthalmoscope, Ac-powered (Class II — Special Controls, product code HLI), submitted by Optovue, Inc. (Fremont, US). The FDA issued a Cleared decision on June 17, 2010, 83 days after receiving the submission on March 26, 2010. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1570.

Submission Details

510(k) Number K100861 FDA.gov
FDA Decision Cleared SESE
Date Received March 26, 2010
Decision Date June 17, 2010
Days to Decision 83 days
Submission Type Special
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code HLI — Ophthalmoscope, Ac-powered
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.1570

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