UNIMAX ANTI-FOG SOLUTION— 510(k) K111622

Name: FDA 510(k) clearance K111622
Creator: U.S. Food and Drug Administration
Published: 2011-09-09

Substantially Equivalent

Unimax Medical Systems, Inc.

FDA 510(k) clearance K111622 for UNIMAX ANTI-FOG SOLUTION, Substantially Equivalent on 2011-09-09. Applicant: Unimax Medical Systems, Inc.. Device class: 2.

Clearance details

Applicant: Unimax Medical Systems, Inc.
Product code: Code OCT
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2011-06-10
Decision date: 2011-09-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taipei County, 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.