IRI INTEGRATED RETINAL IMAGER— 510(k) K062295

Name: FDA 510(k) clearance K062295
Creator: U.S. Food and Drug Administration
Published: 2006-10-20

Substantially Equivalent

Medivision Medical Imaging, Ltd.

FDA 510(k) clearance K062295 for IRI INTEGRATED RETINAL IMAGER, Substantially Equivalent on 2006-10-20. Applicant: Medivision Medical Imaging, Ltd.. Device class: 2.

Clearance details

Applicant: Medivision Medical Imaging, Ltd.
Product code: Code HKI
Device class: Class 2
Regulation: 21 CFR 886.1120
Advisory panel: Ophthalmic
Date received: 2006-08-07
Decision date: 2006-10-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kfar Saba, IL

Download summary PDF View on FDA.gov ↗

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