TOPCON 3D OCT-1000 OPTICAL COHERENCE TOMOGRAPHY SYSTEM— 510(k) K063388

Name: FDA 510(k) clearance K063388
Creator: U.S. Food and Drug Administration
Published: 2007-06-22

Substantially Equivalent

Topcon Corp.

FDA 510(k) clearance K063388 for TOPCON 3D OCT-1000 OPTICAL COHERENCE TOMOGRAPHY SYSTEM, Substantially Equivalent on 2007-06-22. 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: 2006-11-08
Decision date: 2007-06-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

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