PL 20/20 INFANT VISION TESTER— 510(k) K883337

Name: FDA 510(k) clearance K883337
Creator: U.S. Food and Drug Administration
Published: 1988-10-31

Substantially Equivalent

Optimed Technologies, Inc.

FDA 510(k) clearance K883337 for PL 20/20 INFANT VISION TESTER, Substantially Equivalent on 1988-10-31. Applicant: Optimed Technologies, Inc.. Device class: 1.

Clearance details

Applicant: Optimed Technologies, Inc.
Product code: Code HOX
Device class: Class 1
Regulation: 21 CFR 886.1150
Advisory panel: Ophthalmic
Date received: 1988-08-09
Decision date: 1988-10-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lawrence, KS, 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.