Tono Vue Non-Contact Tonometer— 510(k) K180820

Name: FDA 510(k) clearance K180820
Creator: U.S. Food and Drug Administration
Published: 2018-12-14

Substantially Equivalent

Crystalvue Medical Corporation

FDA 510(k) clearance K180820 for Tono Vue Non-Contact Tonometer, Substantially Equivalent on 2018-12-14. Applicant: Crystalvue Medical Corporation. Device class: 2.

Clearance details

Applicant: Crystalvue Medical Corporation
Product code: Code HKX
Device class: Class 2
Regulation: 21 CFR 886.1930
Advisory panel: Ophthalmic
Date received: 2018-03-29
Decision date: 2018-12-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taoyuan City, TW

Download summary PDF View on FDA.gov ↗

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