TRC-NW8 NON-MYDRIATIC RETINAL CAMERA— 510(k) K130289

Name: FDA 510(k) clearance K130289
Creator: U.S. Food and Drug Administration
Published: 2013-05-10

Substantially Equivalent

Topcon Corp.

FDA 510(k) clearance K130289 for TRC-NW8 NON-MYDRIATIC RETINAL CAMERA, Substantially Equivalent on 2013-05-10. Applicant: Topcon Corp.. Device class: 2.

Clearance details

Applicant: Topcon Corp.
Product code: Code HKI
Device class: Class 2
Regulation: 21 CFR 886.1120
Advisory panel: Ophthalmic
Date received: 2013-02-05
Decision date: 2013-05-10
Decision: Substantially Equivalent
Clearance type: Special
Location: North Reading, MA, US

Download summary PDF View on FDA.gov ↗

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