MODEL 5400 OPTOKINETIC STIMULATOR— 510(k) K822917

Name: FDA 510(k) clearance K822917
Creator: U.S. Food and Drug Administration
Published: 1982-11-01

Substantially Equivalent

Life-Tech Intl., Inc.

FDA 510(k) clearance K822917 for MODEL 5400 OPTOKINETIC STIMULATOR, Substantially Equivalent on 1982-11-01. Applicant: Life-Tech Intl., Inc.. Device class: 1.

Clearance details

Applicant: Life-Tech Intl., Inc.
Product code: Code HOW
Device class: Class 1
Regulation: 21 CFR 886.1200
Advisory panel: Ophthalmic
Date received: 1982-10-01
Decision date: 1982-11-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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