Intraocular Pressure Tonometer EASYTON— 510(k) K190382

Name: FDA 510(k) clearance K190382
Creator: U.S. Food and Drug Administration
Published: 2019-12-06

Substantially Equivalent

Company Elamed

FDA 510(k) clearance K190382 for Intraocular Pressure Tonometer EASYTON, Substantially Equivalent on 2019-12-06. Applicant: Company Elamed. Device class: 2.

Clearance details

Applicant: Company Elamed
Product code: Code HKX
Device class: Class 2
Regulation: 21 CFR 886.1930
Advisory panel: Ophthalmic
Date received: 2019-02-19
Decision date: 2019-12-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Yelatma, RU

Download summary PDF View on FDA.gov ↗

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