OZONE GENERATOR
FDA 510(k) clearance K043207 · decided 2005-11-04
Clearance details
- K-number
- K043207
- Device name
- OZONE GENERATOR
- Applicant
- Ge Infrastructure Water & Process Technologies
- Decision
- Substantially Equivalent
- Date received
- 2004-11-19
- Decision date
- 2005-11-04
- Days to decision
- 350 days
- Clearance type
- Traditional
- Product code
- NII
- Device class
- 2
- Regulation number
- 876.5860
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Minnetonka, MN, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| HEMOCLEAN (K023064) | Krd Co., Ltd. | 2004-04-06 |
Recalls involving this device
No recalls on record reference this clearance.