FRESENIUS 2008 BSS BEDSIDE DIALYSIS SYSTEM
FDA 510(k) clearance K890329 · decided 1989-05-11
Clearance details
- K-number
- K890329
- Device name
- FRESENIUS 2008 BSS BEDSIDE DIALYSIS SYSTEM
- Applicant
- Fresenius USA, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1989-01-23
- Decision date
- 1989-05-11
- Days to decision
- 108 days
- Clearance type
- Traditional
- Product code
- FIL
- Device class
- 2
- Regulation number
- 876.5820
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Concord, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| CRIT-LINE MONITOR III TQA (CLM TQA) (K011741) | Hemametrics | 2002-07-23 |
| SPS 550-IPS (INTEGRATED PATIENT STATION) (K901038) | Baxter Healthcare Corp | 1990-04-19 |
| REPGREEN ULTRAFILTRATION MONITOR (K790824) | Cyberex Corp. | 1979-06-27 |
| ULTRAFILTRATION SCALE (K781633) | Extracorporeal Medical Specialities, Inc. | 1978-12-07 |
| ULTRAFILTRATION MONITOR 5M9034 (K771875) | Travenol Laboratories, S.A. | 1977-11-30 |
| AK-10 (K771227) | Gambro, Inc. | 1977-08-02 |
| NEGATIVE PRESSURE ADAPTER 5M1350 (K770137) | Travenol Laboratories, S.A. | 1977-02-01 |
Recalls involving this device
No recalls on record reference this clearance.