OPTICAL COHERENCE TOMOGRAPHY 3D OCT-2000— 510(k) K092470

Name: FDA 510(k) clearance K092470
Creator: U.S. Food and Drug Administration
Published: 2009-09-02

Substantially Equivalent

Topcon Corp.

FDA 510(k) clearance K092470 for OPTICAL COHERENCE TOMOGRAPHY 3D OCT-2000, Substantially Equivalent on 2009-09-02. Applicant: Topcon Corp.. Device class: 2.

Clearance details

Applicant: Topcon Corp.
Product code: Code OBO
Device class: Class 2
Regulation: 21 CFR 886.1570
Advisory panel: Ophthalmic
Date received: 2009-08-12
Decision date: 2009-09-02
Decision: Substantially Equivalent
Clearance type: Special
Location: Tokyo, JP

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.