FDA Product Code
FDA Product Code ONW — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.5860
510(k) Clearances — 4 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K242269 | SC+ Hemodialysis Device (SC-14269); Dialysate Cartridge (SC-14656); Blood Tube Set (SC-14651) | Quanta Dialysis Technologies, Ltd. | 2024-11-01 | Traditional | PDF ↗ |
| K124035 | 2008K@HOME HEMODIALYSIS MACHINE | Fresenius Medical Care North America | 2013-07-03 | Traditional | PDF ↗ |
| K121421 | FRESENIUS 2008K HOME HEMODIALYSIS MACHINE WITH WIRELESS WETNESS DETECTOR (WETALERT) | Fresenius Medical Care North America, Design Cente | 2013-01-17 | Special | PDF ↗ |
| K070049 | FRESENIUS 2008K @HOME WITH WIRELESS WETNESS DETECTOR | Fresenius Medical Care North America | 2011-02-03 | Traditional | PDF ↗ |
Product code ONW · Class II · Gastroenterology, Urology. Data: openFDA.