NON-MYDRIATIC RETINAL CAMERA, MODEL TRC-NW8F— 510(k) K100207

Name: FDA 510(k) clearance K100207
Creator: U.S. Food and Drug Administration
Published: 2010-02-12

Substantially Equivalent

Topcon Corp.

FDA 510(k) clearance K100207 for NON-MYDRIATIC RETINAL CAMERA, MODEL TRC-NW8F, Substantially Equivalent on 2010-02-12. 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: 2010-01-25
Decision date: 2010-02-12
Decision: Substantially Equivalent
Clearance type: Traditional
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.