510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K043207Substantially Equivalent

Ozone Generator

GE Infrastructure Water & Process Technologies, Minnetonka MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K043207 is the FDA 510(k) clearance record for OZONE GENERATOR, a class II device, cleared for Ge Infrastructure Water & Process Technologies on under FDA product code NII (Disinfectant, Dialysate Delivery System). FDA's definition for product code NII reads: "Disinfectant intended for reprocessing dialysate delivery systems". FDA records list one 510(k) clearance for Ge Infrastructure Water & Process Technologies. As of , FDA records show no recalls naming K043207.

Clearance record

Decision date
Received
(350 days to decision)
Product code
NII Disinfectant, Dialysate Delivery System
Regulation
21 CFR 876.5860
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Ge Infrastructure Water & Process Technologies 5951 Clearwater Dr., Minnetonka MN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NII

Trailing 12 months

FDA records hold no clearances under product code NII in the trailing twelve months.

FDA records show no clearances under product code NII in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code NII, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260