YZ3 PORTABLE SLIT LAMP— 510(k) K131711

Name: FDA 510(k) clearance K131711
Creator: U.S. Food and Drug Administration
Published: 2014-05-09

Substantially Equivalent

Suzhou 66 Vision Tech Co., Ltd.

FDA 510(k) clearance K131711 for YZ3 PORTABLE SLIT LAMP, Substantially Equivalent on 2014-05-09. Applicant: Suzhou 66 Vision Tech Co., Ltd.. Device class: 2.

Clearance details

Applicant: Suzhou 66 Vision Tech Co., Ltd.
Product code: Code HJO
Device class: Class 2
Regulation: 21 CFR 886.1850
Advisory panel: Ophthalmic
Date received: 2013-06-11
Decision date: 2014-05-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Suzhou, Jiangsu, CN

Download summary PDF View on FDA.gov ↗

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