DIGITAL RETINAL CAMERA CX-1— 510(k) K092565

Substantially Equivalent

Canon Components, Inc.

FDA 510(k) clearance K092565 for DIGITAL RETINAL CAMERA CX-1, Substantially Equivalent on 2010-03-18. Applicant: Canon Components, Inc.. Device class: 2.

Clearance details

Applicant
Canon Components, 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
Traditional
Location
Lake Success, NY, US
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