DIGISCOPE OPHTHALMIC CAMERA— 510(k) K990205

Name: FDA 510(k) clearance K990205
Creator: U.S. Food and Drug Administration
Published: 1999-03-26

Substantially Equivalent

Eye Tel Imaging, Inc.

FDA 510(k) clearance K990205 for DIGISCOPE OPHTHALMIC CAMERA, Substantially Equivalent on 1999-03-26. Applicant: Eye Tel Imaging, Inc.. Device class: 2.

Clearance details

Applicant: Eye Tel Imaging, Inc.
Product code: Code HKI
Device class: Class 2
Regulation: 21 CFR 886.1120
Advisory panel: Ophthalmic
Date received: 1999-01-21
Decision date: 1999-03-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Centreville, VA, US

Download summary PDF View on FDA.gov ↗

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