OZONE GENERATOR— 510(k) K043207

Name: FDA 510(k) clearance K043207
Creator: U.S. Food and Drug Administration
Published: 2005-11-04

Substantially Equivalent

Ge Infrastructure Water & Process Technologies

FDA 510(k) clearance K043207 for OZONE GENERATOR, Substantially Equivalent on 2005-11-04. Applicant: Ge Infrastructure Water & Process Technologies. Device class: 2.

Clearance details

Applicant: Ge Infrastructure Water & Process Technologies
Product code: Code NII
Device class: Class 2
Regulation: 21 CFR 876.5860
Advisory panel: Gastroenterology, Urology
Date received: 2004-11-19
Decision date: 2005-11-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minnetonka, MN, US

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