FDA Product Code
FDA Product Code ODN — 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 |
|---|---|---|---|---|---|
| K150472 | NxStage System One | Nxstage Medical, Inc. | 2015-06-04 | Special | PDF ↗ |
| K141752 | NXSTAGE SYSTEM ONE | Nxstage Medical, Inc. | 2014-12-19 | Traditional | PDF ↗ |
Product code ODN · Class II · Gastroenterology, Urology. Data: openFDA.