FLA
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Monitor, Temperature, Dialysis
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5820
- Medical specialty
- Gastroenterology, Urology
- Flags
- Life-sustaining
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| NXSTAGE EXPRESS FLUID WARMER (K140623) | Nxstage Medical, Inc. | 2014-06-16 |
| FLUID WARMER (K842302) | Organon Teknika Corp. | 1984-08-27 |
| FLO-TEMP (K810021) | Laminar Flow Industries | 1981-01-23 |
Track FLA automatically
Every clearance here is in the API, with alerts when new ones post.