FDA Product Code
FDA Product Code NII — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.5860
510(k) Clearances — 2 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K043207 | OZONE GENERATOR | Ge Infrastructure Water & Process Technologies | 2005-11-04 | Traditional | PDF ↗ |
| K023064 | HEMOCLEAN | Krd Co., Ltd. | 2004-04-06 | Traditional | PDF ↗ |
Product code NII · Class II · Gastroenterology, Urology. Data: openFDA.