NON-MYDRIATIC RETINAL CAMERA, MODEL CR6-45NM— 510(k) K980246

Name: FDA 510(k) clearance K980246
Creator: U.S. Food and Drug Administration
Published: 1998-05-06

Substantially Equivalent

Canon USA, Inc.

FDA 510(k) clearance K980246 for NON-MYDRIATIC RETINAL CAMERA, MODEL CR6-45NM, Substantially Equivalent on 1998-05-06. Applicant: Canon USA, Inc.. Device class: 2.

Clearance details

Applicant: Canon USA, Inc.
Product code: Code HKI
Device class: Class 2
Regulation: 21 CFR 886.1120
Advisory panel: Ophthalmic
Date received: 1998-01-23
Decision date: 1998-05-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lake Success, NY, US

Download summary PDF View on FDA.gov ↗

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