DIGITAL RETINAL CAMERA— 510(k) K111612

Substantially Equivalent

Canon, Inc.

FDA 510(k) clearance K111612 for DIGITAL RETINAL CAMERA, Substantially Equivalent on 2011-09-14. Applicant: Canon, Inc.. Device class: 2.

Clearance details

Applicant
Canon, Inc.
Product code
Code HKI
Device class
Class 2
Regulation
21 CFR 886.1120
Advisory panel
Ophthalmic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Honkomagome, Bunkyo-Ku Tokyo, JP
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