IMAGESCAPE DIGITAL RETINAL IMAGE SYSTEM— 510(k) K971685

Name: FDA 510(k) clearance K971685
Creator: U.S. Food and Drug Administration
Published: 1997-06-24

Substantially Equivalent

Tomey Corporation USA

FDA 510(k) clearance K971685 for IMAGESCAPE DIGITAL RETINAL IMAGE SYSTEM, Substantially Equivalent on 1997-06-24. Applicant: Tomey Corporation USA. Device class: 2.

Clearance details

Applicant: Tomey Corporation USA
Product code: Code HKI
Device class: Class 2
Regulation: 21 CFR 886.1120
Advisory panel: Ophthalmic
Date received: 1997-05-07
Decision date: 1997-06-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

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