NON-CONTACT TEAR FILM THERMOGRAGH— 510(k) K111771

Name: FDA 510(k) clearance K111771
Creator: U.S. Food and Drug Administration
Published: 2011-11-30

Substantially Equivalent

United Integrated Services Co., Ltd.

FDA 510(k) clearance K111771 for NON-CONTACT TEAR FILM THERMOGRAGH, Substantially Equivalent on 2011-11-30. Applicant: United Integrated Services Co., Ltd.. Device class: 2.

Clearance details

Applicant: United Integrated Services Co., Ltd.
Product code: Code HKI
Device class: Class 2
Regulation: 21 CFR 886.1120
Advisory panel: Ophthalmic
Date received: 2011-06-23
Decision date: 2011-11-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hsin Chu City, TW

Download summary PDF View on FDA.gov ↗

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