510(k) K043207
K043207 is an FDA 510(k) premarket notification submitted by Ge Infrastructure Water & Process Technologies for the device "OZONE GENERATOR". The FDA issued a decision of Substantially Equivalent on November 4, 2005. The device falls under product code NII (Disinfectant, Dialysate Delivery System), a Class II device regulated under 21 CFR 876.5860.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 4, 2005
- Date Received
- November 19, 2004
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Disinfectant, Dialysate Delivery System
- Device Class
- Class II
- Regulation Number
- 876.5860
- Review Panel
- HO
- Submission Type
Disinfectant intended for reprocessing dialysate delivery systems.