RTVUE XR OCT— 510(k) K120238

Substantially Equivalent

Optovue, Inc.

FDA 510(k) clearance K120238 for RTVUE XR OCT, Substantially Equivalent on 2012-04-03. 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: 2012-01-26
Decision date: 2012-04-03
Decision: Substantially Equivalent
Clearance type: Special
Location: Fremont, CA, US

Download summary PDF View on FDA.gov ↗

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