DIGITAL RETINAL CAMERA— 510(k) K102013

Name: FDA 510(k) clearance K102013
Creator: U.S. Food and Drug Administration
Published: 2010-10-29

Substantially Equivalent

Canon Inc. -Medical Equipment Group

FDA 510(k) clearance K102013 for DIGITAL RETINAL CAMERA, Substantially Equivalent on 2010-10-29. 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: 2010-07-16
Decision date: 2010-10-29
Decision: Substantially Equivalent
Clearance type: Special
Location: Tachikawa-Shi, Tokyo, JP

Download summary PDF View on FDA.gov ↗

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