510(k) K771227
- Device
- AK-10
- Applicant
- Gambro, Inc.
- 510(k) number
- K771227
- Product code
- FIL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1977-08-02
- Date received
- 1977-07-07
- Regulation
- 876.5820
- Classification name
- System, Dialysate Delivery, Single Pass
- Medical specialty
- Gastroenterology, Urology
- Review panel
- Gastroenterology, Urology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- N
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3030733800
- 1225714
- 3010838917
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code FIL#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K011741 | CRIT-LINE MONITOR III TQA (CLM TQA) | Hemametrics | 2002-07-23 |
| K901038 | SPS 550-IPS (INTEGRATED PATIENT STATION) | Baxter Healthcare Corp | 1990-04-19 |
| K890329 | FRESENIUS 2008 BSS BEDSIDE DIALYSIS SYSTEM | Fresenius USA, Inc. | 1989-05-11 |
| K790824 | REPGREEN ULTRAFILTRATION MONITOR | Cyberex Corp. | 1979-06-27 |
| K781633 | ULTRAFILTRATION SCALE | Extracorporeal Medical Specialities, Inc. | 1978-12-07 |
| K771875 | ULTRAFILTRATION MONITOR 5M9034 | Travenol Laboratories, S.A. | 1977-11-30 |
| K770137 | NEGATIVE PRESSURE ADAPTER 5M1350 | Travenol Laboratories, S.A. | 1977-02-01 |