FDA Product Code
FDA Product Code FIL — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.5820
510(k) Clearances — 8 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K011741 | CRIT-LINE MONITOR III TQA (CLM TQA) | Hemametrics | 2002-07-23 | Traditional | PDF ↗ |
| K901038 | SPS 550-IPS (INTEGRATED PATIENT STATION) | Baxter Healthcare Corp | 1990-04-19 | Traditional | PDF ↗ |
| K890329 | FRESENIUS 2008 BSS BEDSIDE DIALYSIS SYSTEM | Fresenius USA, Inc. | 1989-05-11 | Traditional | PDF ↗ |
| K790824 | REPGREEN ULTRAFILTRATION MONITOR | Cyberex Corp. | 1979-06-27 | Traditional | PDF ↗ |
| K781633 | ULTRAFILTRATION SCALE | Extracorporeal Medical Specialities, Inc. | 1978-12-07 | Traditional | PDF ↗ |
| K771875 | ULTRAFILTRATION MONITOR 5M9034 | Travenol Laboratories, S.A. | 1977-11-30 | Traditional | PDF ↗ |
| K771227 | AK-10 | Gambro, Inc. | 1977-08-02 | Traditional | PDF ↗ |
| K770137 | NEGATIVE PRESSURE ADAPTER 5M1350 | Travenol Laboratories, S.A. | 1977-02-01 | Traditional | PDF ↗ |
Product code FIL · Class II · Gastroenterology, Urology. Data: openFDA.