Search Results
Found 1 results
510(k) Data Aggregation
K Number
K043207Device Name
OZONE GENERATOR
Manufacturer
GE INFRASTRUCTURE WATER & PROCESS TECHNOLOGIES
Date Cleared
2005-11-04
(350 days)
Product Code
NII, FIN
Regulation Number
876.5860Why did this record match?
Applicant Name (Manufacturer) :
**GE INFRASTRUCTURE WATER **& PROCESS TECHNOLOGIES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The O3Z Ozone System is an optional accessory for the Solution Delivery Systems (SDS) manufactured by GE Infrastructure, Water & Process Technologies and is intended to be used for disinfection of the SDS bicarb mixing and distribution system. The mix tank of the SDS system is filled with either RO or deionized water and the mix tank ozone concentration is increased to 0.70 mg/L. The solution is then distributed to the distribution tank of the SDS system. From the distribution tank, the ozonated water is distributed throughout the distribution loop of the SDS system until a minimum ozone concentration level of 0.30 mg/L is established at the end of the SDS bicarb distribution loop. The solution is then recirculated for a minimum of 15 minutes throughout the distribution system. To complete the disinfection process, the system is then rinsed with RO or deionized water until the system is residual free of ozone.
Device Description
The Ozone Generating System attaches to the Solution Delivery System (SDS) through a valve bypass system and an injector. It is wall mounted in the vicinity of the SDS and is connected to the injector, which is installed in the output piping of the mix pump. The SDS mix tank is filled with RO or DI water; the bypass valves are manually configured for ozone production and then the mix pump is started, causing the injector to draw O3/air mixture into solution. When the proper concentrations of ozone are achieved, the ozonated water is re-circulated throughout the mixing and delivery system to disinfect the fluid path.
Ask a Question
Page 1 of 1