DIGITAL RETINAL CAMERA— 510(k) K123208

Name: FDA 510(k) clearance K123208
Creator: U.S. Food and Drug Administration
Published: 2013-03-19

Substantially Equivalent

Canon Inc. -Medical Equipment Group

FDA 510(k) clearance K123208 for DIGITAL RETINAL CAMERA, Substantially Equivalent on 2013-03-19. Applicant: Canon Inc. -Medical Equipment Group. Device class: 2.

Clearance details

Applicant: Canon Inc. -Medical Equipment Group
Product code: Code HKI
Device class: Class 2
Regulation: 21 CFR 886.1120
Advisory panel: Ophthalmic
Date received: 2012-10-12
Decision date: 2013-03-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bunkyo-Ku, 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.