The following data is part of a premarket notification filed by Ge Infrastructure Water & Process Technologies with the FDA for Ozone Generator.
| Device ID | K043207 |
| 510k Number | K043207 |
| Device Name: | OZONE GENERATOR |
| Classification | Disinfectant, Dialysate Delivery System |
| Applicant | GE INFRASTRUCTURE WATER & PROCESS TECHNOLOGIES 5951 CLEARWATER DRIVE Minnetonka, MN 55343 |
| Contact | Charlene Nash |
| Correspondent | Charlene Nash GE INFRASTRUCTURE WATER & PROCESS TECHNOLOGIES 5951 CLEARWATER DRIVE Minnetonka, MN 55343 |
| Product Code | NII |
| CFR Regulation Number | 876.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-11-19 |
| Decision Date | 2005-11-04 |
| Summary: | summary |