Home / 510(k) Clearances / K771875

510(k) K771875

ULTRAFILTRATION MONITOR 5M9034 by Travenol Laboratories, S.A. — Product Code FIL

K771875 is an FDA 510(k) premarket notification submitted by Travenol Laboratories, S.A. for the device "ULTRAFILTRATION MONITOR 5M9034". The FDA issued a decision of Substantially Equivalent on Nov 30, 1977. The device falls under product code FIL (System, Dialysate Delivery, Single Pass), a Class II device regulated under 21 CFR 876.5820. Travenol Laboratories, S.A. has 205 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Nov 30, 1977
Date Received
Oct 5, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device classification

Device Name
System, Dialysate Delivery, Single Pass
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type
510(k)

Other clearances by Travenol Laboratories, S.A.

  • K874181 — BAXTER BEDSIDE SYSTEM (Feb 22, 1988)
  • K873894 — CONTINU-FLO SOLUTION W/CHECK VALVE 2 Y-INJECT SITE (Nov 5, 1987)
  • K873873 — RESUBMITTED MICRON TRANSFUSION FILTER (Oct 22, 1987)
  • K873984 — AUTOMATIC PERITONEAL DIALYSIS CYCLER SET (5C4437) (Oct 20, 1987)
  • K872364 — HEMODIALYSIS (SPS), MODEL 550, CODE 5M1309 (Oct 13, 1987)
  • K872652 — UPGRADED AUTO PERITONEAL DIALYSIS CYCLER SYSTEM (Sep 30, 1987)
  • K870801 — FLO-GARD 6200 VOLUMETRIC INFUSION/PUMPING BLOOD (Sep 4, 1987)
  • K871908 — IV ADMINISTRATION SET (Jul 27, 1987)
  • K871471 — CAPILLARY FLOW DIALYZERS MODELS ST-12 & ST-15 (Jun 12, 1987)
  • K865029 — CONTINU-FLO SOLUTION ADMIN. SET W/IN-LINE FILTER (Apr 17, 1987)

Other clearances for product code FIL

  • K011741 — CRIT-LINE MONITOR III TQA (CLM TQA) (Jul 23, 2002)
  • K901038 — SPS 550-IPS (INTEGRATED PATIENT STATION) (Apr 19, 1990)
  • K890329 — FRESENIUS 2008 BSS BEDSIDE DIALYSIS SYSTEM (May 11, 1989)
  • K790824 — REPGREEN ULTRAFILTRATION MONITOR (Jun 27, 1979)
  • K781633 — ULTRAFILTRATION SCALE (Dec 7, 1978)
  • K771227 — AK-10 (Aug 2, 1977)
  • K770137 — NEGATIVE PRESSURE ADAPTER 5M1350 (Feb 1, 1977)

FDA data resources

Source: FDA 510(k) database entry for K771875. Report a data issue: hello@regdatalab.com.