FDA Product Code
FDA Product Code ODX — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.5820
510(k) Clearances — 4 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K130554 | REDSENSE ALARM SYSTEM | Redsense Medical AB | 2013-11-22 | Traditional | PDF ↗ |
| K103242 | REDSENSE-ALARM UNIT AND SENSOR | Redsense Medical AB | 2011-02-10 | Traditional | PDF ↗ |
| K092955 | REDSENSE-HOME USE | Redsense Medical AB | 2010-05-10 | Traditional | PDF ↗ |
| K071013 | REDSENSE | Redsense Medical AB | 2007-10-18 | Traditional | PDF ↗ |
Product code ODX · Class II · Gastroenterology, Urology. Data: openFDA.