AMD Anti-Fog Solution— 510(k) K181887

Name: FDA 510(k) clearance K181887
Creator: U.S. Food and Drug Administration
Published: 2019-01-22

Substantially Equivalent

Advanced Medical Design Co., Ltd.

FDA 510(k) clearance K181887 for AMD Anti-Fog Solution, Substantially Equivalent on 2019-01-22. Applicant: Advanced Medical Design Co., Ltd.. Device class: 2.

Clearance details

Applicant: Advanced Medical Design Co., Ltd.
Product code: Code OCT
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2018-07-13
Decision date: 2019-01-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New Taipei 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.