TOPCON 3D OCT-1000 OPTICAL COHERENCE TOMOGRAPHY SYSTEM FOR MEASUREMENT OF RETINAL THICKNESS— 510(k) K072971

Name: FDA 510(k) clearance K072971
Creator: U.S. Food and Drug Administration
Published: 2009-01-13

Substantially Equivalent

Topcon Medical Systems, Inc.

FDA 510(k) clearance K072971 for TOPCON 3D OCT-1000 OPTICAL COHERENCE TOMOGRAPHY SYSTEM FOR MEASUREMENT OF RETINAL THICKNESS, Substantially Equivalent on 2009-01-13. Applicant: Topcon Medical Systems, Inc.. Device class: 2.

Clearance details

Applicant: Topcon Medical Systems, Inc.
Product code: Code OBO
Device class: Class 2
Regulation: 21 CFR 886.1570
Advisory panel: Ophthalmic
Date received: 2007-10-22
Decision date: 2009-01-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

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