XODUS MEDICAL ANTI-FOG SOLUTION— 510(k) K063587

Name: FDA 510(k) clearance K063587
Creator: U.S. Food and Drug Administration
Published: 2007-01-09

Substantially Equivalent

Xodus Medical, Inc.

FDA 510(k) clearance K063587 for XODUS MEDICAL ANTI-FOG SOLUTION, Substantially Equivalent on 2007-01-09. Applicant: Xodus Medical, Inc.. Device class: 2.

Clearance details

Applicant: Xodus Medical, Inc.
Product code: Code OCT
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2006-12-01
Decision date: 2007-01-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New Kensington, PA, US

Download summary PDF View on FDA.gov ↗

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