MODIFIED DEVICE FOR SELF EXAMINATION OF EYES— 510(k) K863429

Name: FDA 510(k) clearance K863429
Creator: U.S. Food and Drug Administration
Published: 1987-01-20

Substantially Equivalent

Wheel Checkers

FDA 510(k) clearance K863429 for MODIFIED DEVICE FOR SELF EXAMINATION OF EYES, Substantially Equivalent on 1987-01-20. Applicant: Wheel Checkers. Device class: 1.

Clearance details

Applicant: Wheel Checkers
Product code: Code HOQ
Device class: Class 1
Regulation: 21 CFR 886.1330
Advisory panel: Ophthalmic
Date received: 1986-09-04
Decision date: 1987-01-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Denver, CO, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.