FUNDUS PHOTO OPHTHALMIC DIGITAL IMAGING SYSTEM, MODEL CFD-440— 510(k) K093071

Name: FDA 510(k) clearance K093071
Creator: U.S. Food and Drug Administration
Published: 2010-11-17

Substantially Equivalent

Fundus Photo, LLC

FDA 510(k) clearance K093071 for FUNDUS PHOTO OPHTHALMIC DIGITAL IMAGING SYSTEM, MODEL CFD-440, Substantially Equivalent on 2010-11-17. Applicant: Fundus Photo, LLC. Device class: 2.

Clearance details

Applicant: Fundus Photo, LLC
Product code: Code HKI
Device class: Class 2
Regulation: 21 CFR 886.1120
Advisory panel: Ophthalmic
Date received: 2009-09-30
Decision date: 2010-11-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Saint Louis, MO, US

Download summary PDF View on FDA.gov ↗

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