510(k) K043207
- Device
- OZONE GENERATOR
- Applicant
- GE INFRASTRUCTURE WATER & PROCESS TECHNOLOGIES
- 510(k) number
- K043207
- Product code
- NII
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2005-11-04
- Date received
- 2004-11-19
- Regulation
- 876.5860
- Classification name
- Disinfectant, Dialysate Delivery System
- Medical specialty
- Gastroenterology/Urology
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- CHARLENE NASH
- Address
- 5951 Clearwater Dr. Minnetonka MN US 55343 55343
FDA Registration Numbers#
- 3005162618
- 9611823
- 3035708507
- 3004111573
- 8030665
- 3005578748
- 3016096143
- 1225714
- 3019131
- 3043014136
- 9611824
- 3015335038
Source Documents#
Other 510(k) Records For Product Code NII #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K023064 | HEMOCLEAN | Krd Co., Ltd. | 2004-04-06 |
Legacy Summary#
summary
FDA Review#
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